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Date

Event
12 December 2013
ISPE Engineers and Project Managers: Blending Skills for a Common Goal

Click Below For Handouts:

http://www.ispeboston.org/files/shah_presentation.pdf

http://www.ispeboston.org/files/faden_presentation.pdf

In the biopharmaceutical industry, almost every project requires a Project Manager (PM) and an Engineering Professional. Although both work towards a common goal they don’t necessarily see “eye to eye” using the same success criteria. Many such differences stem from each person’s experience, perspective and responsibilities.

Engineers honor their professional rigor and best practices. Project managers balance the best interests of stakeholders and functional areas, while meeting the triple constraints of scope, cost, and schedule to deliver a high quality product, service or result.

This program will address ways for the PM and the Engineer to work better to meet the overall objectives of a successful project. The use of various tools, techniques and enhanced overall project knowledge will be the focus.

PRESENTATION ONE: Project Engineering Under ASTM E2500

We first examine the role of the GMP Project Engineer in light of ASTM E2500, ICH Q8, and ICH Q9. These guides require the involvement of a subject matter expert (SME) with a technical understanding of the critical aspects of manufacturing to drive specifications, design and verification, using QRM (Quantitative Risk management) throughout.

Partnering a Project Engineer with a Project Manager can help bring the required SME perspective. The PE and PM have different skills and focus which, when combined, can lead to more efficient and effective project delivery. The project manager can focus on the business aspect and administrative tasks while the project engineer can focus on GEP (Good Engineering Practice) and the technical aspects related to product quality. A review of the PM tool WBS (work breakdown structure) will also be provided.

SPEAKER ONE:

Andrew Faden, CPIP, PMP is a consultant in Project Management, Validation, and Controls and Automation. He received his BS in Electrical Engineering from UMass Amherst, and his MS in Bioscience Administration from Worcester Polytechnic Institute. Andrew gained experience in industrial controls as an Applications Engineer at Klockner-Moeller and Siemens Energy and Automation. In 1996 he took this experience to AstraZeneca, Westborough, MA, where he managed facilities and equipment projects in their parenteral manufacturing plant in support of new product launches. In 2011 he began a contracting career, providing both validation and project management services to pharmaceutical manufacturing clients in Southern California, Colorado, and Massachusetts. After receiving his CPIP, Andrew helped facilitate the Spring 2013 CPIP Study Group.

PRESENTATION TWO: PM Competency for Successful Projects

Project management competency is critical for engineers and engineering teams. Engineers contribute to the delivery of project outcomes within the triple constraints (schedule, cost, scope) while delivering a quality output within resource constraints.

Engineers are critical to the success of projects that involve process or product design, setting up new facilities, process development, manufacturing process automation, product or technology transfer from process development to internal or external manufacturing, and IT infrastructure projects. Engineers are innovative in designing new processes, making improvements to processes/products, developing flawless systems, or conducting detailed root cause analysis of failures.

Yet engineers tend to overlook the big picture when they work on project teams in delivering such initiatives. Engineering teams need to understand the changing dynamics of project lifecycles, project management processes, the significance of people side of projects, managing stakeholder expectations and aligning with other cross functional groups. Project management is an under-utilized tool, where engineering can create significant value by driving the project outcomes.

The second session will highlight two key aspects of project management capabilities that the engineering groups must definitely focus on before they kick off a cross functional project. First is Project Concept and Feasibility (highlighting design and execution/implementation risks), and second, Planning People Management (Project Organization, Stakeholder Management and Communication).

SPEAKER TWO:

Neeraj Shah, MBA, PMP,SAPM, is the Associate Director of IT for Global Supply Chain and Manufacturing at Shire Pharmaceuticals and volunteers as the Director of Education at Boston APICS Chapter #10. He is a regular speaker on Project Management at conferences organized by APICS, Mass Bio Council, and NESCON Conferences, and is the chief instructor of the "Project Management Professional Certification Workshop", for the Boston Chapter of APICS.

Over 18 years Neeraj has successfully orchestrated and delivered business solutions by leading complex cross functional projects spanning supply chain, finance, quality, IT, validation, regulatory and engineering. His core competency lies in project management, leadership, strategy development, stakeholder management and senior management interfacing skills with a strong focus on business process management and integrating projects with organizational goals.Neeraj has worked in multiple supply chain disciplines within Bio-Pharmaceutical, as well as multiple industry verticals such as CPG, High Tech, etc., for organizations like Shire Pharmaceuticals, Biogen Idec, Welch’s, General Electric, General Motors, etc.

Neeraj has an MBA from Babson College, PMP, with a BS in Industrial Engineering from Bangalore University, India

REGISTRATION FEES:

 Before 12/5/2013: Member $30.00  Non-Member $55.00**

 After 12/5/2013: Member: $55.00  Non-Member: $75.00**

Students: Free to attend

**Non-members may only attend one program as a non-member

20 November 2013
CPIP Study Group - Session 9

This is Session 9 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

14 November 2013
The Massachusetts Biotech Super Cluster. A Panel Discussion on Trends in Real Estate Development

Click Below For Handouts:

http://www.ispeboston.org/files/industry_snapshot_2013_final_copy1.pdf

It has been an eventful few years watching the economic engine that is BioTech lead the Massachusetts economy in our region and some would argue, globally. Join us for an interactive and informative evening with industry leaders representing many of the best and brightest firms in our area.  Interact with individuals with wide and varied backgrounds in Real Estate Development, Government Affairs, Design, Real Estate Brokerage and the Owner as we take a look back at what drives our development which supports our innovation economy. Learn about the combined efforts of professionals within these fields that help define and shape the future of our tech cluster and provide innovative work spaces for the next wave of discovery and support the path to the clinic and ultimately commercial launch.  Consider the latest industry metrics for job growth and development in our cluster as it relates to other global clusters of innovation.  Our panel will consider the impact of individual projects within the major regions of our cluster including Cambridge, South Boston, 128 and 495 West while discussing the impact of economic incentives, lease rates, design requirements and the influx of investments and M&A activity.

This program is designed with audience participation in mind so please bring your questions and observations.

Who should attend:

Individuals interested in learning about some of the recent trends at the confluence of facility design, development, owner requirements and public / private investment and the combined effect on our region.

 

PANELISTS:

Dan Cordeau is Vice President of Leasing for Alexandria Real Estate Equities, based in the company’s Cambridge regional office. Dan is responsible for leasing strategy for the Greater Boston portfolio and leasing activity for key vacancies. Prior to joining Alexandria in 2011, Dan was a top broker for Jones Lang Lasalle and has over 25 years of experience in the real estate community with a specialization in the life science industry. Dan was co-manager of the Jones Lang LaSalle National Life Science Group and previously headed the Colliers National Life Science Practice.  Dan has an undergraduate degree from Boston College.

Jeremy Hood is Vice President of T3 Advisors in the Boston Massachusetts office and is a member of the firm’s Healthcare and Life Science sectors. Prior to joining the T3, Jeremy spent four years with a large local landlord where he gained invaluable real estate experience and an extensive understanding of the built environment. Jeremy has participated in hundreds of lease transactions focusing on laboratory requirements as both a landlord representative and tenant broker. Jeremy’s knowledge and passion of laboratory design and construction has been essential in navigating building options for his clients.  Jeremy is currently serving on the Board of Directors of the Commercial Brokers Association.

Peter Abair is MassBio’s Director of Economic and Global Affairs. In this position, he provides consulting services to companies looking to locate to or grow in Massachusetts, manages MassBio's global partners programs, and leads the development and publication of the Industry Snapshot - MassBio's annual economic analysis of the life sciences industry.  Prior to joining MassBio, he served the Commonwealth of Massachusetts in several economic development functions including Director of the Massachusetts Department of Economic Development, Massachusetts Office of Business Development, and Associate Director of the Massachusetts Department of Housing and Community Development. He has served in the administrations of four governors and began his career on the Washington, D.C. staff of the late Congressman Silvio O. Conte.  Peter holds a Bachelor of Arts degree in History and International Relations from Boston University and a Masters in Public Policy and Administration from the University of Massachusetts at Amherst.  A native of Pittsfield, MA, he now resides with his family in Sudbury, where he serves on several local boards.

Phil Plottel is ARIAD Pharmaceutical’s Senior Director of Global Real Estate and Facilities. In this position, he is responsible for delivering ARIAD’s new 380’000 SF new headquarters in Cambridge MA, as well as facilities in Europe, Asia and the Americas. Prior to joining ARIAD, he founded Telshire LLC, a boutique strategic consulting firm; was key in establishing the Novartis Institutes for BioMedical Research where he headed at various times the Real Estate, Design, and Engineering and Construction functions; and started his career as a bridge engineer working on early designs of the Zakim bridge. Phil holds Engineering degrees from Columbia University and the University of Texas, and a Masters in Business Administration from the Yale School of Management. Phil resides with his family in Newton, where he serves on the City of Newton Economic Development Commission.

 

Thank you to our Program Sponsor: 

PROGRAM SCHEDULE:

5:30 – 6:30 PM     Registration & Networking Reception

6:30 – 8:30 PM     Welcome & Program

 

Registration Fees: 

Onsite: Member: $55.00  Non-Member: $75.00**

Students: Free to attend

**Non-members may only attend one program as a non-member

13 November 2013
CPIP Study Group - Session 8

This is Session 8 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

30 October 2013
CPIP Study Group - Session 7

This is Session 7 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

24 October 2013
ISPE Halloween Social Event

Join us for ISPE's Halloween Social Event!

Thursday, October 24, 2013
Flat Top Johnny's
1 Kendall Square, Cambridge, MA 02139

The Halloween celebration will include; Networking, traditional food, live DJ and More!

*Costumes are optional*

Member Rate: $10

Non-Member Rate: $20

23 October 2013
CPIP Study Group - Session 6

This is Session 6 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

16 October 2013
CPIP Study Group - Session 5

This is Session 5 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

9 October 2013
CPIP Study Group - Session 4

This is Session 4 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

2 October 2013
ISPE Annual Product Show and Educational Seminars

ISPE + means being greater than the sum of our parts.  Be a part of the greater sum and join us at the 22nd Annual Product Show at Gillette Stadium in Foxborough, MA.  With an expanded exhibitor area + educational sessions + career fair + vendor showcase + entertainment zone + after party, this year's Show promises to be the best yet.

Keynote Address: Hear from Robert K. Coughlin, President and CEO, Massachusetts Biotechnology Council

Educational Sessions: Register to attend any of the four broad-based programs.
This Old Plant" Performing Projects and Manufacturing Operations Concurrently
How Leaders are Harmonizing our Biopharm Industry Standards
Single Use Technologies-Real Life Experiences
Biotech 101: A Bird's Eye View of the Basics
Career Development Panel: What you should know about the Life Sciences Marketplace; Empowering You to Increase Your Value in the Workplace
Career Development: The Massachussets Life Sciences Center Internship Challenge

After Party: with New England Patriots Running Back Stevan Ridley at Bar Louie, Patriot Place

Schedule:
Registration Opens: 10:00 am
Educational Seminars: 10:30 am to 1:15 pm
Exhibitor Show Floor: 12:00 pm to 7:30 pm
Career Center: 12:00 pm to 5:00 pm
Keynote Address: 1:30 pm to 3:30 pm
Career Development Panel: 3:15 pm to 4:15 pm
Internship Challenge Program: 4:30 pm to 5:30 pm 
After-Show Networking Reception: 7:30 pm to 9:30 pm

The Show, Career Fair, Keynote, Social and all Educational Sessions are FREE!! Register Today!

25 September 2013
CPIP Study Group - Session 3

This is Session 3 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

19 September 2013
Dual Track Seminar: CIP and SIP

TRACK 1: Round table discussion of Steam-in-Place and Clean-in-Place

The round table discussion will be a practical round table discussion of clean-in-place and steam-in-place concepts from design, development, and qualification. Different subjects will be posed to the panel but open to the audience to discuss. The program will be kept intimate in order to maximize the ability of the attendees to interact both with the panel but also with one another. Different topics surrounding cleaning and steam sterilization processes will be selected to engage the audience and panel around current industry issues. The purpose of this program is to not just scrape the surface of these subjects but to dig a little deeper by using the collective knowledge of the panel and attendees. Learn from others’ successes and failures in this interactive forum.

ROUND TABLE LEADERS:

Phil Boncer, Shire Pharmaceuticals

Philip Boncer has twenty-one years of experience in process and validation engineering for the pharmaceutical and medical device industries. He is currently a Senior Validation Engineer at Shire Pharmaceuticals. Prior to that, he was the Principal of P Boncer Consulting for 14 years, a firm that provided validation and process engineering services on a project basis to pharmaceutical and medical device companies mainly in the Southern California area.  He has worked on the design and qualification (including commissioning, installation, operational, performance, process, clean-in-place, steam-in-place, and clean-out-of-place) of a wide variety of systems, including: clean rooms, HVAC, and building management; utility systems such as WFI, clean compressed air, process gases, heat transfer fluids, and process waste; process streams such as automated formulation, homogenization, spray drying, blending, mixing, lyophilization, filling, sterilization, and clean-in-place; and support systems such as autoclaving, depyrogenation, vial and stopper washing, equipment and component washing, and temperature controlled areas/units.

Ronald Berk, Hyde Engineering

Mr. Berk has over twenty four years of process design of process and utility systems, fourteen of which has been in the bio-pharmaceutical industry. He has been the principal engineer on numerous conceptual, detailed design projects and construction support for biopharmaceutical facilities. This includes production process modeling and debottlenecking, the modeling of utilities (water systems, CIP, gas systems and liquid nitrogen) to size the generation, storage and distribution system. Additionally, he has provided support on troubleshooting of contamination and utilization issues on existing purified water systems.

 

TRACK 2: Seminar 101-Going back to school on cleaning and sterilization processes

Clean-in-Place and Steam-in-Place 101

Are the basics of cleaning and sterilizing of equipment baffling to you? Then this is the course for you. You will learn about AFo to Z Value. This intro session will give you the basics of CIP and SIP. If you are new to the industry or have not been exposed to cleaning or sterilization processes, this track will give you the basics to understand the critical aspects of these processes. Cleaning and steaming processes are subjects that come under intense regulatory scrutiny and are critical to pharmaceutical processing. Learn about these important topics from an industry expert.

SPEAKER:

Dawn Tavalsky, Genzyme

Dawn Tavalsky is currently the Director of Quality Assurance Validation at Genzyme, a Sanofi Company in Framingham MA. She has worked in an FDA regulated industry for 23 years and has been a cleaning validation SME for 12 years. Prior to Genzyme, Dawn worked at Sanofi Pasteur, Lonza, Stryker, and Merck. Before she entered the pharmaceutical industry, Dawn was a Lieutenant Nuclear Power School Instructor for the US Navy. She holds a BS in Chemistry, Biology and Nuclear Engineering and a Masters in Business Administration. 

 

SCHEDULE:

Registration: 5:30 pm to 6:00 pm
Networking Reception: 5:30 pm to 6:30 pm
Presentations: 6:30 pm to 8:30 pm
(Track 1 and 2 run cocurrently)

REGISTRATION FEES: PLEASE NOTE NEW LOWER RATES FOR THIS DUAL-TRACK PROGRAM

By 09/12/2013:
Members $30
Non Members $55*
Student Members FREE

After 09/12/2013:
Members $40
Non Members $75*
Student Members FREE

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

18 September 2013
CPIP Study Group - Session 2

This is Session 2 of the CPIP Fall Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

11 September 2013
CPIP Study Group Introductory Session

The US Food and Drug Administration (FDA) contacted ISPE directly and asked ISPE to create a credential of pharmaceutical excellence recognizing comprehensive knowledge in the pharmaceutical industry in order to ensure drug quality and enhance patient safety. ISPE formed an independent Professional Certification Commission and developed the only global competency standard in the world, the Certified Pharmaceutical Industry ProfessionalTM, or CPIPTM credential.

The CPIP credential is valuable to you because it:

- Establishes the only global competency standard for pharmaceutical industry professionals
- Provides a professional development pathway to advance your career
- Provides a comprehensive understanding of all stakeholder needs in an organization
- Unlocks greater career opportunities
- Recognizes your expertise in the industry and among peers
- Gives your employer the competitive advantage of a recognized credential

The Boston Area Chapter is poised to help you attain this credential by sponsoring study groups. If you elect to pursue this credential on your own, you would need to invest over $2,500 to purchase the course materials.  However, when you participate in an organized CPIP study group, ISPE has agreed to furnish these materials absolutely free!  This saves you over $2,500 in course costs. The study group concept gives you the additional advantage of sharing ideas with other like-minded individuals seeking to advance their position in the industry.  The study group concept has been pioneered in Boston and is being refined and improved with each successive offering.  To date, this concept has been extremely successful and our study groups have a passing rate of about 90% on the certification exam.  Last year, Boston Area Chapter study groups produced over 60% of the new CPIP’s in the world.

Study group leaders have participated in one of the Chapter sponsored study groups, passed the exam, and helped to organize the flow of material, bringing all their practical experience to the session in order to make it easier for you to be successful.  The upcoming fall study group will be led by Brian Hagopian, CPIP who attained the credential in 2012.  Several other Boston Area CPIPs will also participate in this study group, sharing the valuable lessons they learned along the way.

Our friends at Pfizer in Andover have generously offered to host this study group, giving us the first opportunity to offer a study group north of Boston.. 

To qualify for the CPIP certification exam (and therefore to attend the study group), a candidate has to meet the following requirements:

1. You must have attained at least a high school diploma or Associates degree and have at least 7 years of industry experience, or 10 years of work experience or
2. You must have attained at least a Bachelor’s degree and have 3 years of industry experience, or 5 years of work experience and
3. You would like to save $2,500 in course materials and
4. You must be willing to invest $150 in your own professional advancement (this covers the cost of food) and
5. You must be an ISPE member or you must join following the introductory session


The CPIP study group is one of the many benefits of belonging to ISPE, but it is important to note that you do not have to be an ISPE member to attend the initial introductory session.

Location: Pfizer, Inc. One Burtt Road, Building F, Room F1300, Andover, MA 01810

Schedule: The study group consists of nine sessions.  The introductory session is being held on Wednesday September 11th. Each session runs from 5:30 to 9:00 PM and includes dinner from 5:30 to 6:00. The schedule for the remaining Wednesday sessions are as follows:

Session 1: 09/11/2013

Session 2: 09/18/2013

Session 3: 09/25/2013

Session 4: 10/09/2013

Session 5: 10/16/2013

Session 6: 10/23/2013

Session 7: 10/30/2013

Session 8: 11/13/2013

Session 9: 11/20/2013

Makeup date of 12/04/2013 reserved if needed. 

Study Group Session Leader: Brian Hagopian, CPIP

Registration: This Boston Chapter sponsored CPIP study group have a one-time registration fee of $150 which covers dinner costs for the nine sessions. Register today at www.ISPEBoston.org/Events. You are free to opt out of the study group after the initial session and if you choose not to continue after the first session, your credit card will not be billed.

Contact Amy Poole, Chapter Manager, at the ISPE Boston office at 781-647-4773 if you have any questions. To join ISPE, go to: http://www.ispe.org/join-or-renew.To learn more about the CPIP program, visit the website at http://www.ispe-pcc.org/index.cfm.

5 September 2013
ISPE Boston Harbor Boat Cruise

Come join the ISPE Boston Area Chapter for our kick-off event of the season! New and returning members, young and old professionals are all welcome to enjoy in a night of socializing and networking as we tour the Boston Harbor waters.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. Hosted by the Boston Belle Charter Company - this is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE Boston Area Chapter. 

Dinner will be provided in the cost of registration. A cash bar will also be available (the boat DOES NOT accept credit cards)

Location:
Boston Harbor Hotel Dock
70 Rowes Wharf, Boston, MA
6:45 P.M. – 10 P.M.
(cruise departs at 7pm sharp)

Registration fees:
Before 08/29
Members: $25
Non-Members: $30

After 08/29
Members: $35
Non-Members: $40

14 August 2013
Product Show Training Camp: How to Make October 2nd Easy, Fun and Profitable!

PROGRAM:

Want to get the most out of your Product Show experience? Do you see other companies breezing in and out of Gillette and wonder how they do it? This informative session will take you from pre-Show marketing, to display best practices, materials load-in, trade show etiquette and a tour of Gillette Stadium that will Show you the quickest way to get around. Hear from Product Show veterans, Gillette Stadium representatives and Capital Convention personnel.

Who Should Attend:
* 
Any Pre-Registered Exhibitors
* First Time Exhibitors
* Anyone that wants to get the most out of their Product Show experience!

REGISTRATION FEES:        
1st Company Attendee           $25
2nd Company Attendee          FREE

 

Click here to download training camp presentation

31 July 2013
ISPE Student Development Committee Planning Meeting

This is a Committee Meeting. If you would like more information regarding the Student Development Committee visit the website at http://www.ispeboston.org/boston_area_student_chapters_home.html or call the office at 781-647-4773.

29 July 2013
ISPE 11th Annual Golf Tournament

SCHEDULE:

7:30 - 8:30 AM - Registration and Continental Breakfast
8:30 AM - Shotgun Start - Scramble Format
1:30 - 3:30 AM - Reception/Cocktails/Buffet Lunch

Please contact the office at (781) 647-4773 if you have any questions about this event.

18 July 2013
ISPE Educational Programs 2014 Season Planning Meeting

ISPE Educational Programs 2014 Season Planning Meeting

 

This summer, the Boston Area Chapter received valuable input on educational programs of interest to our Members. The Educational Program Committee has reviewed this information and we would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Thursday, July 18, 2013.

Schedule 5:30 PM - 8:30 PM Dinner, planning the 2014 programming year, and brief committee meeting

Attendance and parking are free (we want your assistance) and food will be provided! 

ISPE Membership is required in order to participate in any Chapter Committee.  To become a member, click here and select the Boston Area Chapter.

16 July 2013
ISPE Young Professionals Volleyball Social

Come join the ISPE Boston Area Chapter Young Professionals for a fun-natured, yet competitive evening of outdoor volleyball on Tuesday, July 16th. We'll have two nets set up for tournament-style play and then head over to the Warren Tavern for post-game nourishment and networking.

Both skilled players and recreational players should feel free to play! If volleyball isn't your thing, come down and cheer on your co-workers and industry peers and join us at the Warren Tavern later that night! Availability is limited to the first 36 participants who sign up.

LOCATION:

Outdoor Volleyball Tournament
Bunker Hill Community College
250 Rutherford Ave
Charlestown, MA 02129

Post-Tournament Social
The Warren Tavern
2 Pleasant Street
Charlestown, MA 02129

SCHEDULE:

6:00 pm – 8:00 pm Volleyball Tournament

8:00 pm - 10:00 pm Networking Social

FEES:

Members $10
Non Members $20

Price includes post-tournament appetizers and cash bar

26 June 2013
ISPE Bluegrass and BBQ Summer Social

Bluegrass

 

Enjoy great bluegrass music and BBQ food (veggie options available) with your friends and colleagues! Network with ISPE members you know and meet new members and guests. Entertainment provided by The Four Legged Faithful band.

Registration Fees:

$10 for ISPE Members
$20 for non-members

Location:

Tommy Doyle’s Pub, 1 Kendall Sq #100, Cambridge, MA

20 June 2013
ISPE Our Process Is Working, Right?: How do you really know? And can you know in the moment?

PROGRAM SUMMARY:

Come join the Boston Area Chapter for a dual track educational program focused specifically on Validation, defined as “the process of using objective evidence to establish that a process consistently produces a product or result meeting a predetermined specification.” Validation is such a broad topic that we can’t possibly cover everything with one program – so we’ve split the program into two concurrent tracks, one introductory and one advanced to best meet the varied needs of our membership. The introductory track consists of two presentations focused on providing attendees with the basics of validation along with why validation is required from an agency, process, and product lifecycle perspective. The advanced track takes a detailed look at validation beginning with a summary of industry and FDA contributions to the FDA Process Validation Guide. Two presentations will then focus on the emerging field of Continuous Process Verification (CPV) describing both a theoretical and actual case study detailing how CPV was implemented by a local life sciences company. The Tufts Gordon Institute in Medford has generously offered their facilities to host this program.

INTRODUCTORY TRACK:

This program begins with an introduction to the key regulatory agencies and their expectations with a practical discussion of product lifecycle implications. Next, the program shifts focus to provide attendees with an overview of validation basics and the key tenets behind validated processes and products. Attendees will come away with an understanding of the mindset behind and importance of integrating the process behind the product.

SPEAKERS:

Rich Yeaton is President of East Coast Validation Services, LLC in Derry, NH, and has over twenty years experience working in FDA regulated industries. He was initially introduced to GMP operations on the Devices side as a Development Engineer in DuPont’s Medical Products division, where he developed and improved new process equipment, and then was told to validate what he had designed.

He moved on to help start Phoenix Imperative, an Engineering and Validation consulting company serving the BioPharm industry. A key achievement with Phoenix was leading validation teams to assist MedImmune to obtain its first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Shire, Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics, a microbial fermentation Contract Manufacturer, to successfully prepare for their first Pre Approval Inspection. He is currently working with a GMP Operating company to manage Process, Cleaning and Equipment validation efforts for a new combination product under development. He is a member of ISPE, PDA and AAMI and has degrees in Electrical Engineering and Mechanical Engineering from Lehigh University.

Jack Campion, PE, has held positions in process design, design-build project management, validation, and validation management for twenty-four years.

He led the commissioning, qualification and process validation program for MassBiologics' 100,000 square foot cell culture and aseptic fill-finish facility in Mattapan. In this role, Jack applied the ISPE Baseline® Guide Volume 5:  Commissioning and Qualification, saving countless labor hours and weeks of schedule through careful system definition and elimination of redundant testing. Jack was also a member of the design team and was responsible for system turnover and acceptance from the construction manager.

Jack holds a BA in chemistry from the College of the Holy Cross and an MS in Chemical Engineering from Tufts University. He is a registered Professional Engineer in Massachusetts. Jack is currently Manager of Project Controls for capital projects at Genzyme's Allston Landing Facility. He is a former Treasurer and current Member of the Board of Directors of the ISPE Boston Area Chapter.

ADVANCED TRACK:

This program takes a deep dive into the practical aspects of Process Validation. ISPE has solicited input from the industry as well as the FDA, and has developed an impressive stable of best practices in Process Validation. Our first presentation reviews the content of these reference materials. The second presentation focuses on the emerging field of Continuous Process Verification (CPV), which is considered the Holy Grail by both the FDA and the industry. Selection of critical process parameters to monitor, analyze data, and respond to process variability will be discussed first as part of a theoretical case study and then as applied in a real world example currently in use. Biogen Idec has developed a quantitative method for chromatogram review/evaluation. Multivariate analyses of the discrete parameters have been applied for evaluation and scale-down model verification. The author shares the journey of electronic chromatogram evaluation including the use of such methodology to identify the root cause for a product quality shift.

SPEAKERS:

Peter Levy has been involved in process development for the BioPharmaceutical and related industries for over 30 years. He began providing consulting services to the Pharmaceutical Industry in the areas of Process Development, Manufacturing, Technical Transfer, and Process Validation in 2007. He received his B.S. degree in Chemistry from Tufts University and M.S. degree in Chemical Engineering from Massachusetts Institute of Technology.

Past employers include Biogen, Inc (Director Development Engineering & Validation), Millennium Pharmaceuticals (Director Biologics Process Development), Altus Pharmaceuticals (Director Process Development & Engineering), and Amicon Division of WR Grace & Company (Manager, Process Filtration Applications). His focus has been on downstream processing of recombinant proteins with an emphasis on liquid-solid separations. His experience includes the development of processes and process equipment as well as technical transfer, start-up, and validation of clinical and commercial protein processes.

Mr. Levy is an active member of ISPE and participated in the ISPE PQLI PV Implementation Team that produced two discussion papers in 2012 and is presently working on 4 more discussion papers related to Process Validation.

Dr. Lilong Huang joined Biogen Idec in 2012 and is currently leading the global advanced process control (APC) initiative within the company. The mission of Biogen Idec’s APC initiative is to transform research, development, and manufacturing data into better process understanding and eventually into actions to achieve improved product quality. Dr. Huang has worked in Chemical, Vaccine, and Biological industries for the past 9 years. Prior to joining Biogen Idec, he worked at Bayer, Merck, and Genzyme. His expertise includes manufacturing support, new facility startup, facility utilization optimization, data analytics and process monitoring/control.

Dr. Huang graduate from Beijing University of Chemical Technology in 1996 with a Bachelor of Science degree and from Tsinghua University in 1999 with a Master of Science degree both in Chemical Engineering. He received a Ph.D. in Chemical Engineering from Lehigh University in Bethlehem, PA in 2004.

Click Here for Handouts from Rich Yeaton

Click Here for Handouts from Jack Campion, PE

Click Here for Handouts from Peter Levy

Click Here for Handouts from Dr. Lilong Huang

 

MEETING MANAGERS:

Brian Hagopian, CPIP, Clear Water Consulting

Armen Nahabedian, Pfizer

Chiderah Okoye, Venly, Inc.

 

SCHEDULE:
Registration & Networking Reception: 5:30 pm to 6:30 pm
Program: 6:30 pm to 8:30 pm
Introductory and Advanced Tracks Run CONCURRENTLY. You Must Choose One to Attend.

REGISTRATION FEES: 
Before 06/13/2013: Members $50
Non Members $95* Student Members FREE

After 06/13/2013: Members $60 Non Members $115* Student Members FREE

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

6 June 2013
ISPE Young Professionals Red Sox Social

Come join the ISPE Boston Area Chapter Young Professionals for a fun-filled Red Sox game against the Texas Rangers on Thursday, June 6th.  We’ll meet to pick up tickets and enjoy some social pre-game beverages at Remy’s Bar.  Availability is limited, so register today!

6:00 pm – Pre-Game Social

Jerry Remy’s Bar
1265 Boylston St  Boston, MA 02215

7:10 pm – Red Sox Game vs. Texas Rangers

Fenway Park

$10 for Members and $20 for Non Members
Limit One Ticket per Person
Pre-Registration is Required

4 June 2013
CPIP Study Group-Session 9

This is Session 9 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

29 May 2013
ISPE Young Professionals Bowling Social

Come join the ISPE Boston Area Chapter Young Professionals at The Flatbread Company in Davis Square for an evening of pizza, socializing, and candlepin bowling at the famous Sacco’s Bowl Haven! Enjoy a variety of wood-fired, clay oven flatbread pizzas (vegetarian options will be offered). Bowling shoes will be provided and a cash bar will be available.

Space is limited, so get your tickets now before it’s too late!

SCHEDULE:

6:00 pm – 7:00 pm Pizza and Networking

7:00 pm - 9:00 pm Bowling

FEES:

Before 05/22/2013:
Members $20
Non Members $30

After 05/22/2013:
Members $25
Non Members $35

21 May 2013
CPIP Study Group-Session 8

This is Session 8 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

16 May 2013
ISPE AUTOMATION: At the Crossroads with IT Interfaces

PROGRAM SUMMARY:


In January 2011 the FDA issued new Guidance for Industry on Process Validation, which replaced guidance issued over 20 years ago. The FDA Guidance is intended to align Process Validation practices with a “lifecycle” concept as well as with the principles outlined in ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems). This session will review the FDA Guidance just issued, and will summarize the efforts of ISPE’s Process Validation Implementation Team, including some practical considerations for implementing the new approach.  In addition, observations from establishing a Stage 3 “Continued Process Verification” program for legacy products will be shared, including challenges and lessons learned.

PRESENTATION ONE:
Process Data Management and the Changing Role of the Automation Engineer
As the need for business and process data grows, companies are commissioning more specialized computerized systems, sometimes with a great deal of overlap leading to redundant data being stored in multiple systems. ANSI/ISA95 (Enterprise-Control System Integration) addresses this problem by setting standards for communications within the enterprise layers of manufacturing and operations. The role of the automation engineer is being transformed into that of a business analyst in order to streamline processes such as materials management, computerized maintenance, and procurement. Service Oriented Architecture, Web Services, and OPC communications will be discussed. Systems to be explored include DCS, MES, EDMS, EQMS, CMMS, and Plant Historians.

SPEAKER ONE:
Jordan Croteau is an Automation Engineer in Biogen Idec Cambridge Manufacturing Engineering. Jordan has served as technical lead for numerous projects on process automation and control and IT systems, with a process data management focus. Before Biogen Idec, Jordan spent three years working for automation integrators and process skid manufacturers. Jordan earned a Bachelor of Science in Chemical Engineering from Worcester Polytechnic Institute, and is a member of the International Society of Automation (ISA) and an Information member of the ISA95, ISA18, and ISA100 committees.


PRESENTATION TWO:
Implementing an Equipment Monitoring System with an Operations Information Infrastructure
This presentation describes the installation of an automated Equipment Monitoring System providing “review by exception” electronic reports with automated routing and e-signature approvals to replace an existing manual paper-based GMP record for logging equipment temperature readings, and related process data and information. The execution of this project required the implementation of a site-wide Operations Information Infrastructure which will also be discussed as the basis on which future “electronic initiative” application projects will be integrated.

SPEAKER TWO:
Kenneth S. Kovacs is the QA Business Systems Manager at Fujirebio Diagnostics, Inc. in Malvern, PA and a Certified Management Consultant (CMC). He has in-depth knowledge in Life Sciences Industry operations, manufacturing, and technology transfer through 35 years of experience working with companies including Johnson & Johnson, TAVA Technologies, and Rockwell Automation.
Ken is an active member of ISPE and GAMP America’s MES SIG. He is an original member of the ISA-95 committee that developed the “Enterprise-Control System Integration” international standard, a past Director of ISA’s Food and Pharmaceutical Industries Division, and a co-author of both the textbook “Automation and Validation of Information in Pharmaceutical Processing” and the GAMP® Good Practice Guide: Manufacturing Execution Systems Control and Compliance”. Ken has a Bachelor of Engineering degree from Villanova University and an MBA from Xavier University.

SPEAKER THREE:
Glenn Restivo is the Director of Business Development Life Sciences, Chemicals, Food and Nutrition for M+W Automation. His role is to develop and promote automation and manufacturing IT solutions for pilot and commercial manufacturing addressing industry, business and regulatory challenges. He focuses his efforts on meeting the customer’s time to market, minimizing project risk, optimizing solutions and using state of the art technology that supports project lifecycle and asset management.
He received a bachelor’s degree in chemical engineering from Stevens Institute of Technology in Hoboken, New Jersey. In addition, he actively participates with the International Society for Pharmaceutical Engineers (ISPE), MIT’s Center for Biomedical Innovation (CBI), Rutgers Engineering Research Center (ERC), Next Generation Pharma Workshops and has articles on PAT/QbD and RFID published in key industry trade magazines.

Click Here for Handouts from Jordan Croteau
Click Here for Handouts from Kenneth Kovacs

Thank you to our Program Sponsor: 

 

SCHEDULE:

Registration & Networking Reception: 5:30 pm to 6:30 pm

Program: 6:30 pm to 8:30 pm

REGISTRATION FEES: 

Before 05/09/2013:
Members $50

Non Members $95*
Student Members FREE

After 05/09/2013:
Members $60
Non Members $115*
Student Members FREE

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

14 May 2013
CPIP Study Group-Session 7

This is Session 7 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

30 April 2013
CPIP Study Group-Session 6

This is Session 6 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

23 April 2013 -
24 April 2013
ISPE INTERPHEX Bus

Traveling to INTERPHEX from the Boston area? Sign up for a Complimentary Roundtrip Shuttle Bus.

Buses will depart Boston on April 23 and 24 at 7am. Return trip departs from the Jacob K. Javits Center in NYC at 6pm on April 23 and 4:30pm on April 24. Take a one-day bus or stay over night.

Pick-up Location: The Rt 128 Parking Lot at Blue Hill Dr & University Avenue Westwood, MA.

NOTE: please disregard any reference to "seminars" or "seminar selection." We had to modify our seminar registration to accept bus reservations. You must select a bus trip below. Thank you.

22 April 2013
ISPE Student AbbVie Plant Tour and Educational Program

PROGRAM SUMMARY:


AbbVie, a worldwide leader in the biopharmaceutical industry, opens the doors of its Worcester facility for a one of a kind tour and educational program geared specifically to students.  A combination of posters, equipment exhibitions, presentations, and employee led tours will give attendees first-hand knowledge of how manufacturing and research are done at AbbVie and will provide valuable insights to students interested in careers in the biopharmaceutical industry.  Gain real world knowledge through this in-depth learning opportunity while building your understanding of some of the career paths available to you.


EDUCATIONAL PROGRAM:

Introduction to Biologics Development & Manufacturing by Gary Welch, Plant Manager, AbbVie

This informative presentation provides background on the manufacturing capabilities at AbbVie’s multi-product biologics manufacturing facility and describes the practical aspects of how cross-functional teams of scientists and engineers are integrated into the process. The presentation is geared towards students and emerging professionals and provides an introduction to biologics development & manufacturing. An overview of common biotech unit operations found in industry will also be presented. The discussion for each unit operation reviews basic theory, principles, and the use of these techniques for antibody production. 

Introduction to Engineering at AbbVie by Steve Granger, Technical Support Manager, AbbVie

This presentation will provide a brief overview of the typical responsibilities of chemical engineers at a biologics manufacturing and launch facility. Typical engineering tasks and decisions will be discussed in the context of the overall asset life cycle for bioprocessing equipment. Designed specifically for new or soon-to-be engineering graduates, the presentation will provide some insight into the day-to-day expectations and responsibilities for practicing chemical engineers in a biopharmaceutical manufacturing environment.

PLANT TOUR:

Employee led tours will bring attendees through AbbVie’s laboratories, scale up area, and production facility providing insights on how the plant operates to develop and produce antibodies. 

PROGRAM SCHEDULE:

4:30 – 5:30 PM     Registration & Networking Reception, Dinner, Posters and Equipment Exhibitions

5:30 – 7:00 PM     Presentations

7:00 – 8:30 PM     Tours of Manufacturing Facility and Cell Culture / Purification Research Laboratories


REGISTRATION FEES:
 

Registration is open only to ISPE Student members.  You must be an ISPE member to attend.

Join ISPE at www.ispe.org/join-or-renew

Registration is required, but the program is free!

18 April 2013
ISPE Facility Tour & Dual-track Seminar


Facility Tour – The New WPI Bioengineering Center
Track 1: Process Validation – Practical Aspects of the New Guidance
Track 2: Biotech 101 – Empowering You with the Basics of Biopharmaceuticals

TRACK 1: Process Validation – Practical Aspects of the New Guidance

In January 2011 the FDA issued new Guidance for Industry on Process Validation, which replaced guidance issued over 20 years ago. The FDA Guidance is intended to align Process Validation practices with a “lifecycle” concept as well as with the principles outlined in ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems). This session will review the FDA Guidance just issued, and will summarize the efforts of ISPE’s Process Validation Implementation Team, including some practical considerations for implementing the new approach.  In addition, observations from establishing a Stage 3 “Continued Process Verification” program for legacy products will be shared, including challenges and lessons learned.

SPEAKER:

Rusty Morrison, Commissioning Agents, Inc
Rusty (Russell) Morrison is the Director of Process and Technical Services for Commissioning Agents, Inc., where he is responsible for the sales, marketing, and execution of process validation and technology transfer projects. He has directed multiple process validation efforts, including the complete process validation for the startup of a large cell culture monoclonal antibody manufacturing facility, and remedial process validation for a manufacturer of numerous small volume sterile parenteral products, including designing a continued process verification program. 

Mr. Morrison is a member of PDA and ISPE, and is currently serving as a member of ISPE’s Process Validation Implementation Team. In addition, he is a past president and current board member of the PDA New England Chapter. Prior to Commissioning Agents, Mr. Morrison held management / engineering positions with Protein Sciences Corporation, INNCOM International, and Sonalysts, Inc., and served as a submarine officer in the United States Navy. He has a BS in chemical engineering with honors from the University of Minnesota and an MBA in Information Systems from Rensselaer Polytechnic Institute.

TRACK 2: Biotech 101 – Empowering You with the Basics of Biopharmaceuticals

What goes on inside a biotech manufacturing facility? How are these lifesaving drugs actually made? What is upstream? What is Downstream? ISPE’s Boston Area Chapter is bringing you the answers to these questions and much more in their Biotech 101 session at WPI.  In this session, we will show you the process of how biotech based drugs are made, the typical systems required to maintain a robust facility, and the critical quality attributes and process parameters associated with manufacturing. No matter what your experience level, this behind the scenes look into drug manufacturing will enhance your understanding of how a single cell is turned into a lifesaving therapy. 

SPEAKER:

Alex Cardoso, Biogen Idec
Alex Cardoso is a Process Engineer at Biogen Idec, where he is responsible for the process support, equipment design and technology transfer projects. He has been a technical lead on all scales of production, taking processes from the initial small scale into large commercial scale, including process validation.  His experience includes both mammalian and microbial production as well as both upstream and downstream activities.

Prior to joining Biogen Idec, Mr. Cardoso held positions in manufacturing/engineering with Lonza, CRC Consulting, and Amgen. He has a BS in Chemical Engineering from the University of Massachusetts Amherst and is a member of ISPE. 

Click Here for Handouts from Rusty Morrison

Click Here for Handouts from Alex Cardoso

 

SCHEDULE:

Registration: 5:30 pm to 6:00 pm
Networking Reception and Facility Tour: 5:30 pm to 6:30 pm
Program: 6:30 pm to 8:30 pm

REGISTRATION FEES: PLEASE NOTE NEW LOWER RATES FOR THIS DUAL-TRACK PROGRAM

Before 04/11/2013:
Members $30
Non Members $55*
Student Members $5

After 04/11/2013:
Members $40
Non Members $75*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

16 April 2013
CPIP Study Group-Session 5

This is Session 5 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

13 April 2013
ISPE Student Poster Contest

ATTENTION STUDENTS! Register to compete in the Annual Student Poster Contest. Two winning students, one each from the graduate and undergraduate categories receive a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in Washington, D.C. on November 3-6, 2013. Winners of the International competition receive cash awards and have the opportunity to publish their materials in ISPE's Pharmaceutical Engineering magazine, as well as other Chapter/Affiliate publications.

For full details about the ISPE International Poster Competition as well as abstracts from previous winners, visit www.ISPE.org/students/poster-competition

Pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE to participate.  Join ISPE at www.ispe.org/join-or-renew.

Register today!

9 April 2013
CPIP Study Group-Session 4

This is Session 4 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

2 April 2013
CPIP Study Group-Session 3

This is Session 3 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

30 March 2013
ISPE Student Career Forum

If you are graduating this year or a few years from now, you will benefit from a workshop designed to help you to hone your skills and improve your chances of getting that internship or permanent position in the Life Sciences Industry.

ISPE Boston has assembled a group of industry experts to help you:

*  Get the Interview
*  Get the Job
*  Build Your Network
*  Build Your Career Path
*  Learn From Industry Pros

Register today for this informative workshop!

28 March 2013
ISPE Medieval Manor: Young Professionals Social

Come join the ISPE Boston Area Chapter Young Professionals at the Medieval Manor for a bawdy but lighthearted interactive romp through the dark ages! Enjoy one-of-a kind entertainment as you feast on six courses without a fork, knife, or spoon (vegetarian meals are available). Beer and Red/White wine will also be provided with the dinner. If you need a vegetarian meal, please contact the office at 781-647-4773 or office@ispeboston.org.

Get there early as there will be a “meet and greet” social at 6:30!

Space is limited, so get your tickets now before it’s too late!

SCHEDULE:

6:30 pm – 7:45 pm Meet and Greet (Cash Bar)

8:00 pm - 10:00 pm Dinner & Show

FEES:

Member: $10
Non-Member: $25

 

28 March 2013
ISPE WPI Life Sciences & Bioengineering Career Fair

Attend the WPI Life Sciences & Bioengineering Career Fair on Thursday, March 28th!

26 March 2013
CPIP Study Group-Session 2

This is Session 2 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

21 March 2013
ISPE The Science and Risk Based Approach to C&Q: The Road to ASTM E2500

PROGRAM SUMMARY:

The introduction of ASTM E2500 and ICH Q9 (Quality Risk Management) have provided the Pharmaceutical Industry with a methodology to optimize commissioning and qualification activities resulting in improved compliance and a defined focus on product quality and patient safety.  Efficient implementation of these practices provides the additional opportunity to reduce capital project timelines, and reduce life cycle costs. 

Although the ASTM and ICH documents indicated the “What” in defining a science and risk based approach to system verification, the “How’s” of practical and efficient implementation of the supporting work processes had not been fully described and associated best practices had not been developed. 

In order to help fill this need, the C&Q CoP sponsored the development of the ISPE Guide: Science and Risk Based-Approach for the Delivery Facilities, Systems, and Equipment that presents a structured life cycle approach to the delivery and verification of GxP regulated facilities, systems, and equipment. It supports the ASTM industry and ICH regulatory initiatives, including science based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concept. In addition the C&Q COP formed a Task Team to develop a Good Practice Guide - Applied Risk Management for C&Q that maps the transition and provides implementation strategies for moving from the traditional, or “Baseline Guide 5 approach” based on Impact Assessment to ICH Q9/ASTM quality risk management implementation. 

This presentation will provide an overview these recent ISPE guidance documents and provide an overview of the implementation principles and elements contained therein.

SPEAKERS:

Dave Dolgin, Senior Quality Program Manager, Quality Systems Group, AbbVie
Dave Dolgin is currently a Senior Quality Program Manager in the Quality Systems group of AbbVie (formerly Abbott). Dave has more than 35 years of Quality Assurance and Validation experience in the pharmaceutical industry and has been with Abbott/AbbVie since 1991.  Dave led the C&Q task team in development of  ISPE’s Good Practice Guide - Applied Risk Management for C&Q.

Steve Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc.
Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. (CAI), provider of technical services for biotech and pharmaceutical manufacturers world-wide. Commissioning Agents focuses on the manufacturing process, with services including commissioning, validation, technology transfer, PAT, maintenance programs, SOPs, training and cGMP compliance.

Mr. Wisniewski offers more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining CAI he was Senior Associate and Director of Compliance for Drug and Device Associates. Mr. Wisniewski has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He served on the ISPE Board of Directors beginning in 1982, and was Chairman of the Board in 1991. He served four terms as Chairman of the ISPE Community of Practice for Commissioning and Qualification, was a lead on the Task Team that drafted the recent ISPE Guide in support of Risk-based Qualification and served on the Task Team that completed the ISPE Good Practice Guide to address transitional Science and Risk-based (ICH Q9) approaches for C&Q. He was on the Team that developed the ASTM E2500 Standard and has also served as course leader and/or presenter at multiple ISPE C&Q conferences and co-authored several C&Q related articles.

Click Here for Handouts from Dave Dolgin

Click Here for Handouts from Steve Wisniewski

 

SCHEDULE:

Registration & Networking Reception: 5:30 pm to 6:30 pm
Program: 6:30 pm to 8:30 pm

REGISTRATION FEES:

Before 03/14/2013:
Members $50
Non Members $95*
Student Members $5

After 03/14/2013:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

19 March 2013
CPIP Study Group

PROGRAM:  

The Certified Pharmaceutical Industry Professional (CPIP) certification demonstrates competence in pharmaceutical industry practices. The study group will prepare industry professionals to qualify for CPIP certification.

Come to an informational meeting to learn more about the CPIP program and the spring study group. Each class will run from 5:30pm-9pm and the cost includes all 9 sessions. If after the informational session you choose not to continue the course, we will refund your registration fee.  

REGISTRATION FEE:
$150

This is a Members-Only Event. If you are not yet a member of ISPE, there's no better time to join! Visit www.ispe.org/join or call (813) 960-2105 today.


SCHEDULE:

Session 1: 3/19/2013 (Introductory Class)

Session 2: 3/26/2013

Session 3: 4/2/2013

Session 4: 4/9/2013

Session 5: 4/23/2013

Session 6: 4/30/2013

Session 7: 5/14/2013

Session 8: 5/21/2013

Session 9: 6/4/2013

16 March 2013
ISPE CEO Free Throw Sponsor at Bio-Ball

Bio-Ball is a unique and exciting opportunity for biotechnology companies of Massachusetts to reap the rewards of volunteerism and invest in the community by sponsoring and staffing a special kind of March Madness. The marriage of the Massachusetts biotechnology industry and Special Olympics Massachusetts centers on a shared goal: the promise of a better tomorrow. While biotechnology companies strive to discover and create the innovations that will make for a healthier future, Special Olympics Massachusetts is dedicated to empowering individuals with intellectual disabilities and other closely related disabilities by giving them opportunities to develop physical fitness, demonstrate courage and participate in a brighter tomorrow. In addition to the synergies between the two organizations, volunteers at Bio-Ball have the unique opportunity to interact with the very beneficiaries of the event itself. The Massachusetts biotechnology industry is making the promise of a better tomorrow a reality by pursuing cures for many of the illnesses and disabilities that affect these athletes. In turn, the resilience of these athletes reminds us all in the biotechnology community why we strive so hard as an industry to persevere and fight to realize our goals of curing disease.

For more information on Special Olympics Massachusetts or to volunteer to help at Bio-Ball, visit their website here.

 

5 March 2013
ISPE UNH Student Chapter Career Fair

Save the Date for the UNH Student Chapter Career Fair!

1 March 2013
ISPE Annual Ski Trip

The Chapter's Annual Ski Trip will be held on March 1, 2013 at Loon Mountain. Space is Limited, so Don't Delay!

Price Includes:
Bus ride up and back, full day adult lift ticket, and a lot of fun with fellow ISPE members!

Note: Books of 4 Tickets are available for $275. If you would like to purchase a Book, please fill out the flyer.

Bus Departures:
5:30 AM: from Newton Marriott - Rt. 128

6:00 AM: from Chateau Restaurant - Andover, MA
7:00 AM: from LL Bean, Concord - NH

Bus Returns:
7:00 PM: to all Departure Sites (Concord, Andover, Newton)

 

Thanks to our Bus Sponsors:
Commissioning Agents, Inc.
GxP Automation LLC
Integra Companies Inc
Perkins+Will
R.W. Sullivan Engineering
SciTech Builders
Sentrol, Inc
Superior Controls, Inc. 
UltraFiltronics

25 February 2013
ISPE Tufts Student Chapter Career Path Panel Discussion

Save the Date for the Tufts Student Chapter Career Path Panel Discussion!

21 February 2013
ISPE FM Global SimZone Tour and Program: Identifying and Mitigating Common Hazards in Business Properties

PROGRAM SUMMARY:

Every year businesses sustain billions of dollars of property damage. Some of these losses could have been prevented had hazards been identified and corrected prior to becoming catastrophic. FM Global, a multinational business property insurance company, has created an experiential learning facility called the SimZone to teach their engineers to identify and mitigate property-loss risks. The FM Global SimZone is a simulation-based classroom that brings to life real-world educational scenarios involving 90% of the common hazards found in typical business properties. These include fire protection, ignitable liquid storage and transfer, construction, equipment malfunction and electrical hazards. In the SimZone, thousands of possible property risk simulations can be created so that attendees may gain real-world experience in identifying and correcting possible hazards. 

This program will give attendees a tour of the SimZone that will provide a rare opportunity to experience some of the training that FM Global provides its own engineers. This MEMBERS ONLY two-hour tour will provide attendees with a hands-on education of state-of-the-art loss-prevention strategies and equipment. The SimZone demonstrates a variety of wall and roof construction, industrial heating equipment, electrical equipment, ignitable liquid storage and use, and warehousing. The facility also includes a fire protection sprinkler system demonstration area complete with an electric and diesel pump, an array of risers, and a variety of sprinkler heads. 

Following the tour and after the reception will be three presentations which are open to Members and Non-Members. The opening presentation will address two aspects of hazardous material storage in the typical process facility. First will be a review of some common steps required to identify hazards in typical process operations and options for reducing the presence or magnitude of these hazards. Following this discussion, our speakers will present code compliant design approaches for fire-protection and separation, based on the use and storage of flammable materials. The last presentation will be a showcase of the research and product testing capabilities at the FM Global Research Campus in West Glocester, R.I. The presentation will highlight the testing conducted at the Fire Technology Lab, Natural Hazards Lab, Electrical Hazards Lab and Hydraulics Lab.

SPEAKERS:

Dennis M. Anderson, P.E., Vice President, Engineering Application Manager, FM Global
Dennis Anderson is vice president, engineering application manager, for FM Global. Based at FM Global’s Research Campus in West Glocester, R.I., USA,Anderson is responsible for addressing client, media, and business partner groups to illustrate the science and engineering capabilities. Appointed to his current position in 2003, Anderson previously served as vice president, chief engineer, and has been with FM Global for over 35 years. Anderson holds a master’s degree in business from Case Western Reserve University in Cleveland, Ohio, USA, and a bachelor’s degree in civil engineering from North Dakota State University, Fargo, N.D. He is a member of the National Fire Protection Association and the Society of Fire Protection Engineers, and is a registered professional engineer in Ohio and Wisconsin.

Eric Peterson, A.I.A., Senior Associate / Project Architect, Symmes Maini & McKee Associates
Mr. Peterson is a Senior Associate and Project Architect at SMMA with over 25 years of experience. A central aspect of his work is the coordination of multiple disciplines in complex projects, and his experience in the technical and code aspects of architectural projects. His design experience includes projects for Shire Pharmaceuticals, Pfizer, Organogenesis, Draper Laboratories, MicroChem Corporation, Lyme Properties and Bose Corporation. Mr. Peterson holds a Bachelor of Science in Architecture and a Master of Architecture from the University of Michigan College of Architecture and Urban Planning.

Howard Sneider, Senior Process Engineer, Clark Richardson Biskup
Mr. Sneider is a Senior Process Engineer at CRB. Previously, he was a Senior Process Engineer at Wyeth Biotech. He has over thirteen years of experience in all phases of process design, process modeling simulations, equipment design and selection, acceptance testing, start-up, commissioning, and validation. Mr. Sneider has participated in, and directed, the design of: biological, vaccine and API manufacturing processes, clean utilities, and facilities. His experience includes green-field and renovation projects at the lab, pilot, and commercial scale. He has worked closely with clients, vendors and construction managers to successfully execute and deliver design packages and construction support services. Mr. Sneider is a member of the ISPE Boston Chapter. He holds a BS degree in Chemical Engineering from Columbia University and a MS is Chemical Engineering from the University of Connecticut. 

Click Here for Handouts from Dennis Anderson

Click Here for Handouts from Eric Peterson

Click Here for Handouts from Howard Sneider


SCHEDULE:

Registration for MEMBERS ONLY TOUR (Four Points Sheraton):  3:30 pm to 4:00 pm
MEMBERS ONLY Tour (FM Global SimZone): 4:00 pm to 6:00 pm
Seminar Registration (Four Points Sheraton): 5:30 pm to 6:00 pm
Networking Reception (Four Points Sheraton): 6:00 pm to 6:45 pm
Presentations and Q & A (Four Points Sheraton): 6:45 pm to 8:45 pm

REGISTRATION FEES:    

Before 02/14/2013:
Members $50
Non Members $95*
Student Members $5

After 02/14/2013:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

5 February 2013
ISPE Membership Drive at Pfizer
23 January 2013
ISPE Young Professionals Biotech Trivia Night

Come join the ISPE Boston Area Chapter Young Professionals for a night of trivia, appetizers, and socializing. Put your thinking caps on for a session of Geeks who Drink Trivia, and compete with your fellow pharmaceutical nerds for bragging rights, exciting prizes, and a raffle to benefit The Red Sox Foundation and Massachusetts General Hospital’s Home Base Program. Proceeds of the event and the 50/50 raffle will be donated to the charity.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. It’s a great opportunity to meet other people from different areas of these stimulating and diverse industries and get involved with the International Society of Pharmaceutical Engineers, all with a little friendly competition and, of course, drink tickets.

Register early; there are a limited number of spots available.  We’ll set up the teams, so all you need to do is be ready to show off your trivia skills.

17 January 2013
ISPE Building Information Modeling (BIM): From Concept to Substantial Completion (and Beyond)

PROGRAM SUMMARY:

There continues to be a great deal of conversation around the topic of building information modeling (BIM) in the design, construction, and facilities management worlds. For designers, BIM offers the opportunity to engage with users in real time to reflect design decisions of lab spaces. Modifying the model during the user meetings, designers and lab users get it right during the design process in lieu of understanding the concept at move-in. BIM also presents new opportunities for streamlining the facilities management process once construction is complete. Using the data in the model allows facilities managers the opportunity to better control space allocations and tracking, evaluate move management and control equipment management. Attendees will understand the realized benefits of an effective BIM implementation (not just in concept but $ and time) with the help of virtual models and a tour.

In the first presentation, HDR will touch on a number of the projects for which BIM was leveraged, as well as present a real-world case study. These real world case studies leveraged BIM to improve the design process, expedite user sign-off, and enhance facilities management capabilities, all making the facility manager’s life easier. The second presentation will be given by the ASC Project Team (UMMS, SCCI, PMA and ARC) who just finished building the showcase project next door. To continue to build on its strengths in medical research and advanced therapeutics and stem cell development, the University of Massachusetts Medical School (UMMS) is creating an interdisciplinary, state of the art research facility designed to encourage interaction and collaboration among researchers and promotes innovation and synergies across disciplines. Under this UMMS Program are three projects totaling $440M that were constructed under the direction of the University of Massachusetts Building Authority (UMBA).

For the University’s 500,000 square-foot Albert Sherman Center (ASC) project, the team has created an intelligent BIM model. The final deliverable will be a model that provides MEP engineering intelligence for future renovations as well as ongoing facilities maintenance with a full online project database which includes O&M’s, Commissioning data, plans, specifications and beyond. The team is also exploring links with the Building Management System (BMS) as well as the computerized maintenance management system (CMMS). When complete, this model may become the basis for BIM usage for the entire UMass system. The Albert Sherman Center will accommodate 300,000 ft2 of space for wet research laboratories, cold rooms, and core research space; and 200,000 ft2 of dry research and educational space, including teaching areas, a 360-seat auditorium, conference center, cafe, fitness center, and support staff spaces. Substantial Completion will be in December 2012 and researchers moving in Spring of 2013.

SPEAKERS:

Brian Sykes, AIA, Architect and Project Manager, HDR Architectures (Bethesda, MD Office)
Brian Sykes, AIAis an architect and project manager with HDR Architecture’s Bethesda, Maryland office. He is focused on leveraging BIM during the design of Science and Technology projects. Before joining HDR, Brian was a BIM Consultant at AEC Infosystems in Baltimore, Maryland, where he focused on support and modeling of federal facilities and BIM implementation at architecture firms across the Mid-Atlantic. Brian earned a Bachelor of Science in Architecture from Clemson University and a Master of Architect from Virginia Tech’s Washington Alexandria Architecture Consortium. He is an adjunct faculty member at Virginia Tech’s WAAC where he teaches sustainability and building technology. Brian is a member of the American Institute of Architects (AIA) and the Washington, DC Building Enclosure Counsel.

John Baker, Associate Vice Chancellor of Facility Management Partner, UMass Medical School
John Baker is the Associate Vice Chancellor for Facility Management at the UMass Medical School, Worcester, MA. He has been in this position for the last ten years and prior to UMass, John served in the U.S. Navy’s Civil Engineer Corps, retiring after twenty years’ service. John earned a Bachelor of Science in Civil Engineering from the University of New Hampshire and a Masters of Science in Construction Engineering and Management from Purdue University. John is a registered professional engineer in New Hampshire and Massachusetts.

Tom Watson, Regional BIM/VDC Director, Suffolk Construction Company
Tom Watson brings 20 years of industry experience as a Mechanical Engineer specializing in mechanical, electrical, and plumbing/fire protection (MEP/FP) on projects spanning the healthcare, education, and commercial market sectors. The majority of his career was spent working as a plumbing and fire protection engineer at Symmes, Maini & McKee Associates, focusing on the engineering design of schools, healthcare, and research facilities.

As one of the regional BIM/VDC Directors at Suffolk, Tom is responsible for developing and maintaining Building Information Modeling (BIM)/Virtual Design and Construction (VDC) processes for all projects. He utilizes 3D modeling for all MEP/ FP systems, identifying potential collisions, clashes, and constructability issues; provides 4D scheduling simulations of construction sequences; supports estimating in extracting quantities from the models (5D); and develops customized 6D Facilities Management solutions to support an owner’s life cycle management of a building. 

Erik Servies, AIA, Associate, PMA Consultants
Erik Servies, AIA is an Associate with PMA Consultants and has been providing Owner’s Project Management services with PMA for over three years. Erik earned a Bachelor of Architecture from Wentworth Institute of Technology and an MBA from Babson College and is a Registered Architect in Massachusetts. Erik is a member of the American Institute of Architects (AIA), the Construction Management Association of America (CMAA) and the Boston Society of Architects (BSA). He is a frequent presenter on BIM in the Boston area, and nationally, focusing on the Owner’s perspective of BIM 6D, BIM implementation and IPD “lite”.

Mark Dolny, AIA, LEED AP, Associate Principal, ARC/ Architectural Resources Cambridge
With over fifteen years at ARC, Mark has an extensive amount of experience with educational clients having managed a large portion of the firm’s academic projects, including master planning and programming. Mark is currently overseeing the Albert Sherman Center (ASC) for the University of Massachusetts Medical School. In this role, he has managed all programming and design for the medical education facilities component of the ASC, specifically the development of the Center for Experiential Learning and Simulation (CELS) and the creation of new Student Learning Communities within the new facility.

Click Here for Handouts from Brian Sykes

Click Here for Handouts from the Panel

SCHEDULE:

Registration and Networking Reception:  5:30 pm to 6:15 pm
Tour: 6:15 pm -6:45 pm
Presentation: 6:45 pm to 9:00 pm

REGISTRATION FEES:    

Before 01/11/2013:
Members $50
Non Members $95*
Student Members $5

After 01/11/2013:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

10 January 2013
ISPE Chapter Excellence and Annual New Year's Celebration Social

In early November at the ISPE Annual Meeting in San Francisco, the Boston Area Chapter was awarded the top honor, the North American/South American Affiliate Council "Platinum Grand Award for Excellence and Innovation" for the fourth year in a row! Thank you to the entire 2011-2012 Board of Directors, Committee Chairs and Volunteers for their commitment to the Chapter and their extraordinary efforts.

Join your friends and colleagues for ice skating, live music, and celebrating! Thursday, January 10th at the Kendall Square Ice Skating Rink at 650 East Kendall Street.

The event is FREE for Members and $20 for Non-Members.

Skating 5:30 to 7:30 pm
Social 6:00 to 10:00 pm

300 Athenaeum Street, Cambridge, MA 02142

13 December 2012
ISPE Serialization Regulations and Technology: Navigating the New Demands of the Distribution Chain

PROGRAM SUMMARY:

The Biopharmaceutical Industry is quickly adopting new technology to secure the drug distribution chain, help assure patient safety, comply with evolving regulations, and enhance the bottom line.

And starting at the bottom line, a local industry analyst (IDC Tech Insights, Framingham) has identified $11 billion in "revenue leakage" that might be reduced by better drug tracking. Stopping the leaks means discouraging diversion from distribution channels, maintaining safe delivery of cold-chain products, and enhancing management of product recalls. Recent recall events in the news have heightened awareness of the criticality to maintain pace with the new serialization technologies and stay ahead of regulatory deadlines.

Evolving standards and regulations both in the US and internationally will soon require all saleable units to have an “e-Pedigree” with real time track-and-trace capability. Track-and-trace allows health care providers to verify critical drug information that helps ensure patient safety. The challenge to Biopharma is big! Fortunately, the technology is emerging quickly, with improved integration that provides robust solutions.

Attendees at this meeting will learn from industry experts who know the regulations and the technology. Attendees will see case studies with examples that deliver real business benefits and assure compliance.

If you are developing new medicines, manufacturing drug products, or distributing them, this meeting applies to you - don’t miss it! Come join us and hear industry experts describe what World-Class companies are doing now!

SPEAKERS:

Mark Hallowell, Barry-Wehmiller Design Group, Director Engineering
Mr. Hallowell has decades of experience in packaging and process automation controls in the pharmaceutical, medical device, and biotech industries. His experience covers Project Management, Packaging Line Control Philosophy and Design, Computer Systems Validation including 21 CFR Part 11 compliance remediation, Master Planning, and Serialization implementation. The experience in Panel Design, Network Communication Architecture, PLC and SCADA design/programming including data extraction and data analysis, coupled with component selection and packaging line commissioning provides complimentary skills required to successfully provide integrated solutions. He is responsible for all aspects of electrical engineering and controls integration associated with automation for the pharmaceutical industry and has implemented numerous Sterilization projects for Big Pharma clients to support pending regulatory requirements. Mark’s experience delivering integrated solutions incorporating various technologies (2D & 3D barcodes, RFID, etc.) into complex packaging lines for a wide range of presentations (Vials, Syringes, bags, etc.) and OEM suppliers adhere to customer specifications as related to general design guidelines, hardware preferences and software development. He works with clients to select control system technology, communication protocols, and developing electrical specifications.

Mike Salinas, M+W U.S., Inc., Director of Manufacturing Technology
Mike Salinas is Director of Manufacturing Technology for M+W U.S., Inc. He has over 25 years of diverse production, process development, facilities planning, design, project management and construction experience for Owner Operating and Engineering Design & Construction firms. At M+W, he specializes in applying consistent, leading-edge manufacturing technology and converting technological know-how into feasible, compliant and operationally efficient design concepts for M+W’s global Life Sciences clients. Mike will provide a general overview of Serialization, discuss the elements for full implementation, and offer some insights on the challenges associated with implementation. Mike earned a Bachelor of Science in Industrial Engineering (BSIE) degree from Columbia University, New York, and a Master of Science in Engineering Management (MSEM) degree from Drexel University, Pennsylvania.

Click Here for Handouts from Mark Hallowell

Click Here for Handouts from Mike Salinas

 

SCHEDULE:

Registration and Networking Reception:  5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:    

Before 12/6/2012:
Members $50
Non Members $95*
Student Members $5

After 12/6/2012:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

4 December 2012
CPIP Study Group-Session 9

This is Session 9 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

27 November 2012
CPIP Study Group-Session 8

This is Session 8 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

20 November 2012
CPIP Study Group-Session 7

This is Session 7 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

15 November 2012
ISPE Marketing Yourself: Empowering You to Increase Your Value in the Workplace

PROGRAM SUMMARY:

Looking to be more successful in gaining new opportunities within the workplace? Or need advice for making the right impression with a potential employer? Discerning employees know there’s a need to go beyond working hard and hoping someone else recognizes them for new openings or promotions. To advance in the workplace it’s critical to learn to “market yourself” and be acknowledged for your unique talents and capabilities. In the competitive world of biopharm, how do you communicate and honestly present yourself in an advantageous way? This session will examine strategies for marketing yourself from multiple perspectives within the industry. The Panelists, drawing from a wealth of experience in recruiting and developing talent in biotech, will provide key insights for boosting personal success throughout the life cycle of a working professional (from the initial interview to mid-level career). So what are you waiting for? Come network (an active component of marketing yourself) and learn the considerations specific to biopharm; empowering you to market yourself to achieve personal success.

Thank you to our Program Sponsor:


PANELISTS:

Alison Neely, Recruiting Partner – Pharmaceutical Operations & Technology, Biogen Idec
Alison has been with Biogen Idec for 1.5 years and is a Recruiting Partner in Cambridge, MA, currently focused on staffing within the Pharmaceutical Operations & Technology division. Alison is currently the Lead Recruiting Partner for Cambridge Manufacturing and Technical Development (an organization with 275 employees split between NC and MA). Prior to joining Biogen Idec, she was a Senior Search Consultant, Life Sciences at HireMinds for 4.5 years, where she led the permanent staffing division, which supported hiring in the Greater Boston area for 50 biotech clients. Before joining the recruiting/staffing industry, Alison received her B.S degree in Microbiology from Virginia Tech.

Michael Pelletier, Director of Engineering and Facilities, Lonza Biologics
Michael Pelletier is the Director of Engineering and Facilities at the Lonza Biologics production facility in Portsmouth, NH. He has worked in the Biotechnology and Medical Device industries for twenty years including seven years at Abbott Laboratories in their Glucose Products group. 

Michael joined Lonza in 2002 as the Automation Project Manager for the Large Scale Build Out project in
Portsmouth NH, and was later Manager of the Controls and Calibration groups at the site. He was responsible for Automation Development and Plant Commissioning activities at the Lonza Biologics Singapore expansion project where he spent three years with his family.

Michael holds a BS in Chemical Engineering from the University of New Hampshire and an MBA from
Northeastern University.

Laura W. Poisson, Vice President, ClearRock, Inc.
Laura Poisson is an HR Professional with 15 years of experience in talent acquisition and career management. In her current role as Vice President for ClearRock, an executive coaching and outplacement firm, she provides career transition support to impacted individuals.

Before joining ClearRock, Laura worked for Liberty Mutual to lead management in developing hiring strategies
to attract and hire top talent. Her communication skills and curiosity provided her with a platform to understand key motivators for both the hiring managers and candidates ensuring the right candidates were introduced to the right opportunities at the right time in their careers.

Prior to Liberty Mutual, Laura spent her time as a headhunter placing professionals in a variety of companies
and industries giving her the beneficial perspective of understanding the nuances and skills required to succeed in both large, Fortune 100 companies as well as small, entrepreneurial environments. She coached candidates and companies on how to effectively market themselves and successfully recruited and placed IT professionals in insurance, professional services and financial services on the East Coast.
Laura has a BA in Psychology from the University of Maine and is a certified MBTI administrator.

Brian Jochim, Account Executive – Clinical Research, Aerotek Scientific, LLC
Brian has been with Aerotek since 2003 where he started as a Technical Recruiter for the Scientific division (supporting the life science industry).  In this role, he sourced and screened candidates for the appropriate job match.  Since 2004, Brian has been an Account Executive where his role is to create partnerships with local biotech and pharmaceutical companies to meet their staffing needs and provide them with top talent.  He prides himself on creating lasting working relationships with clients and candidates to ensure a long-term fit. 


Click Here for Handouts from Alison Neely 

Click Here for Handouts from Michael Pelletier

Click Here for Handouts from Laura Poisson

Click Here for Handouts from Brian Jochim

 

SCHEDULE:

Registration and Neworking Reception:  5:30 pm to 6:20 pm
Panel Presentations: 6:20 pm to 8:30 pm
Group Q & A: 8:30 pm to 9:00 pm

REGISTRATION FEES:    

Before 11/08/2012:
Members $50
Non Members $95*
Student Members $5

After 11/08/2012:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

1 November 2012
ISPE Day of the Dead Social

Our celebration of the dead will include: Networking, Traditional Food, Live DJ, and more! Costumes are optional. We will host a fundraiser benefitting "We Beat Cancer", so bring your luck for the raffle. 

30 October 2012
CPIP Study Group-Session 6

This is Session 6 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

23 October 2012
CPIP Study Group-Session 5

This is Session 5 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

16 October 2012
CPIP Study Group-Session 4

This is Session 4 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

3 October 2012
ISPE Annual Product Show and Educational Seminars

Get Back to the Future - Biotech and pharmaceutical firms are once again investing in new products and research. Register today for the Chapter’s flagship event and learn about the current and future state of biopharm.

Keynote Address: Hear from Peter Moesta, Senior. Vice President, Biologics Manufacturing & Process Development, Bristol-Myers Squibb

Educational Sessions: Register to attend any of the four broad-based programs.

Click below for meeting handouts.

The FDA-483 and Beyond: David Chesney
ASME BPE: Reinhard Hanselka, PhD, REA and Raymond Foley
Massachusetts Life Science Real Estate: Peter McManus, Timothy Stoll, and Jeremy Hood
Integrated Commissioning and Qualification: Jack Greene
Keynote Address: Peter Moesta 

After Party: Meet Jerod Mayo, New England Patriots Linebacker

Schedule:
Educational Seminars: 10:30 am to 1:15 pm
Exhibitor Show Floor: 12:00 pm to 7:30 pm
Career Center: 12:00 pm to 7:30 pm
Keynote Address: 3:30 pm to 4:45 pm
After-Show Networking Reception: 7:30 pm to 9:30 pm

The Show, Career Fair, Keynote, Social and all Educational Sessions are FREE!! Register Today!

2 October 2012
CPIP Study Group-Session 3

This is Session 3 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

25 September 2012
CPIP Study Group-Session 2

This is Session 2 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

20 September 2012
ISPE This Old Plant (even if its New) - Performing Retrofit Projects in an Operating Facility

PROGRAM SUMMARY:

From the (relatively) simple addition of a WFI drop to a major plant expansion, performing mechanical work in an operating GMP facility presents significant challenges. Often the project timeline is driven more by an absolute requirement to maintain or resume nearby manufacturing rather than traditional scope and resource loading, and in these cases it may also be more important to minimize the operational impacts than to optimize the project design. This session will first examine some of the not-so-obvious ways that facility design can impact project design in both old and relatively new plants. It will then focus on how operational considerations can constrain project execution and what planning steps can be taken to offset those constraints.

Thank you to our Program Sponsor:

SPEAKER:

Rick Kotosky, P.E. / Senior Process Engineer / Integrated Process Technologies, Inc.
Rick has over 20 years experience in the biotech industry in positions ranging from Process Engineer to Senior Director of Facilities Operations. His engineering design work has included renovation of both cell culture and purification suites from single to multi-product use and expansion of WFI distribution systems. In his Facilities Operations roles he has been responsible for planning and executing numerous full plant shutdowns for retrofit work in facilities ranging from 5 to over 100 years of age, and he has managed start-up of a new facility without impact to adjacent GMP manufacturing operations that shared utilities with the new building. He has recently completed a significant upgrade of bioreactor SIP operations, expanding scope to include renovation of clean steam distribution piping while maintaining project schedule for return to manufacturing operations. Rick holds a BS degree in Chemical Engineering from MIT and an MBA from Boston University.

Click here to view handouts from Rick Kotosky

SCHEDULE:

Registration and Neworking Reception:  5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:    

Before 09/13/2012:
Members $50
Non Members $95*
Student Members $5

After 09/13/2012:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

18 September 2012
CPIP Study Group

PROGRAM:  
The Certified Pharmaceutical Industry Professional (CPIP) certification demonstrates competence in pharmaceutical industry practices.  The study group will prepare industry professionals to qualify for CPIP certification.

Come to an informational meeting to learn more about the CPIP program and the fall study group.  Each class will run from 6pm-9pm and the cost includes all 9 sessions.  If after the informational session you choose not to continue the course, we will refund your registration fee.  

REGISTRATION FEE:
$150

This is a Members-Only Event.  If you are not yet a member of ISPE, there's no better time to join! Visit www.ispe.org/join or call (813) 960-2105 today.


SCHEDULE:

Session 1: 9/18/2012 (Free Introductory Class)

Session 2: 9/25/2012

Session 3: 10/02/2012

Session 4: 10/16/2012

Session 5: 10/23/2012

Session 6: 10/30/2012

Session 7: 11/06/2012

Session 8: 11/27/2012

Session 9: 12/04/2012

6 September 2012
ISPE Young Professionals Boat Cruise

Come join the ISPE Boston Area Chapter ,Young Professionals for our kick-off event of the season! New and returning Members are welcome to enjoy in a night of appetizers, socializing, and networking as we tour the Boston waters.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. Hosted by the Boston Belle Charter Company- this is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE.

Boston Harbor Hotel Dock
70 Rowes Wharf, Boston, MA
6:45 pm – 10 pm
(ship leaves  7pm)

Registration fees:    before 09/4   after 09/4
Members:                    $25             $35
Non-Members:             $30              $40

16 August 2012
ISPE Young Professionals Softball Game

The Challenge: The ‘Young Professionals’ challenge the ‘Seasoned Veterans’ to a game of Softball.

The Stakes: The team that does NOT prevail will purchase the 1st round at Beacon Hill Pub, 149 Charles St, Boston, MA 02114 immediately following the game.

So grab your glove, do some stretching, and come support your comrades in an epic battle of newbie vs. old guard, young-at-work vs. young-at-heart, freshmen vs. seniors, rookie vs. done-that…you get the picture.  The goal is to have a fun game (with some competitive rivalry) ,so both skilled and unskilled players are encouraged to play.  Or if sports are not your thing, come be a fan and enjoy the views along the river.

Note: Parking is extremely limited. Public transportation is the best way to reach the field: either the Charles/MGH stop on the red line or Science Park stop on the Green line. Paid parking is available at the Mass Eye & Ear Infirmary Parking Lot; Metered parking is along Charles Street.


DON’T FORGET TO REGISTER BEFORE THE LINE-UP IS DECIDED!

30 July 2012
ISPE 10th Annual Golf Tournament

SCHEDULE:
7:30 - 8:30 AM - Registration and Continental Breakfast
8:30 AM - Shotgun Start - Scramble Format
1:30 - 3:30 PM - Reception/Cocktails/Buffet Lunch

REGISTRATION FEES:
$1,000/Foursome (includes Continental breakfast, lunch, and golf for each player)
Foursomes are sold out, but please contact the office (office@ispeboston.org) to be put on a waitlist.

25 July 2012
ISPE Educational Programs 2012-2013 Season Planning Meeting

This summer, the Boston Area Chapter received valuable input on educational programs of interest to our Members. The Educational Program Committee has reviewed this information and we would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please come to a meeting at The Conference Center at Waltham Woods on Wednesday, July 25, 2012.

Schedule
5:30 PM – 8:30 PM
Dinner, planning the 2012-2013 programming year, and brief committee meeting

Attendance and parking are free (we want your assistance) and food will be provided! 

ISPE Membership is required in order to participate in any Chapter Committee.  To become a member, click here and select the Boston Area Chapter.

28 June 2012
ISPE Summer Social and 20th Anniversary Party

Join your friends and colleagues in celebrating our Chapter’s 20th birthday! Network with members you know and meet new members and guests.

Have a Hawaiian shirt or luau attire? Wear it.

Ono (delicious) appetizers will be served.

Thanks to our Sponsors:

GOLD:
R.W. Sullivan Engineering

SILVER:
Perkins + Will
Furniture Consultants, Inc.
The Richmond Group

BRONZE:
NELSON

21 June 2012
ISPE Single-Use Systems for Biopharmaceutical Manufacturing: The End User's Perspective

JOINT ISPE BOSTON AREA AND NEW ENGLAND CHAPTER PROGRAM

SUMMARY:

Single-use systems offer critical benefits to the end users in the form of lower initial capital expenditures, reduced cleaning requirements, faster turnaround times, reduced risk of product cross-contamination and shorter installation/implementation times. However, these benefits are coupled with a number of challenges. The program is designed to provide the end users’ perspective on the development and large scale commercial use of single-use systems. Attendees will gain an understanding of the challenges encountered with single-use systems during technical development, design, startup and routine operational use as well as strategies to address these at various stages of deployment.

The ISPE Boston Area and New England Chapters are also glad to present a rare opportunity to tour Shire’s manufacturing facility in Lexington utilizing single-use technologies at commercial scale.

Membership has its privileges!

Thank you to our Program Sponsor:

Thank you to our Program Sponsor: 

SESSION I: Development of Process Technology Platforms based on Single-Use Systems

Presented by: Christopher Adams, Shire HGT, Associate Director of Pilot Operations
The session will provide key considerations for the development of process technology platforms based on single-use systems. The presenter will share knowledge and real-life experience gained through design, development and integration of single-use systems in support of an end-to-end fully disposable cell culture process. Based on the lessons learned, key points to consider and a holistic approach to facilitate a thorough upfront evaluation of single-use systems will be reviewed.

SESSION II: Deployment of Single-Use Systems for Large Scale Commercial Manufacturing

Presented by: Mark McElligott, Process Design Solutions, Partner / Principal Engineer
The session will provide an overview for the deployment of single-use systems in commercial large scale manufacturing of biopharmaceuticals. The presenter will share knowledge and hands-on experience gained through the startup and routine operational support of a fully disposable large scale cell culture facility. The unique challenges encountered during startup of a single-use facility as well as various strategies employed to address routine operational challenges will be reviewed.

SCHEDULE:
4:00 – 5:30 PM           Tours SOLD OUT
5:30 – 6:20 PM           Registration and Networking Reception
6:20 – 6:30 PM           Welcome and Program Introduction
6:30 – 8:30 PM           Program

Click here to view handouts from Christopher Adams

Click here to view handouts from Mark McElligott

REGISTRATION FEES:
Before 06/14/2012:
Members $50
Non Members $95*
Student Members $5

After 06/14/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

7 June 2012
Product Show Training Camp: How to Make October 3rd Easy, Fun and Profitable!

PROGRAM:
Want to get the most out of your Product Show experience? Do you see other companies breezing in and out of Gillette and wonder how they do it? This informative session will take you from pre-Show marketing, to display best practices, materials load-in, trade show etiquette and a tour of Gillette Stadium that will Show you the quickest way to get around. Hear from Product Show veterans, Gillette Stadium representatives and Capital Convention personnel.

Who Should Attend:
*
Any Pre-Registered Exhibitors
* First Time Exhibitors
* Anyone that wants to get the most out of their Product Show experience!

PROGRAM SCHEDULE:
1:30 – 2:30 PM           Registration and Networking Reception
2:30 – 4:00 PM           Program, Q&A
4:00 – 5:00 PM           Tour of Loading Docks and Show Floor, Wrap-up and Final Q&A 

REGISTRATION FEES:       
1st Company Attendee           $25
2nd Company Attendee          FREE

22 May 2012
CPIP Study Group-Session 9

This is Session 9 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

15 May 2012
CPIP Study Group-Session 8

This is Session 8 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

10 May 2012
ISPE Process Design: From Scientific Concept to Engineering Reality

PROGRAM SUMMARY:
The Process Design is one of the most challenging areas for Biopharm manufacturers. There are three unit operations that require consideration: Cell Culture, Clarification, and Downstream Purification. Each of these unit Operations informs the design of facilities and equipment. There are Regulatory, Quality, Science and Engineering considerations that are always part of successful Process Design, but also important is experience of what "works" in a Production environment and what doesn't. This session will examine all of this in the hope of explaining how processes end up getting designed and also provide hints on how to avoid common pitfalls. The Panelists represent leading figures who have designed many such processes and will share their wisdom and experiences.

Click Here for Meeting Handouts from Doyle Johnson

Click Here for Meeting Handouts from Rajesh Beri

Click Here for Meeting Handouts from Judy Bodette

Click Here for Meeting Handouts from Anton Edmund

Click Here for Meeting Handouts from Christian Lim

MODERATOR:
Doyle Johnson, New England Operations Leader, Hargrove Engineers + Constructors
Mr. Johnson is the New England Operations Leader for Hargrove Engineers + Constructors. Previously, he was the Senior Director of Facilities Operations at Genzyme’s Biologics Division. He has more than 25 years of experience designing, building and operating BioPharma and Chemical Process Plants. Mr. Johnson currently serves on the ISPE International Board of Directors. Mr. Johnson served as President of the ISPE Boston Chapter, and prior to that served for five years on the Board of Directors of the Boston Chapter. Under his leadership the Boston Chapter implemented a Young Professionals Initiative, a GAMP program at the Product Show and won the Chapter Excellence award for North America. He has lived and worked in both the US and Europe. He holds a BS degree in Chemical Engineering from Cornell University, an MS in Organic Chemistry from Northeastern University and an MBA from Babson College. 

PANELISTS:
Rajesh Beri, Ph.D., Director, Manufacturing Sciences and Technology, Lonza Biologics
Rajesh Beri received his Bachelors of Technology in Chemical Engineering from the Indian Institute of Technology, Mumbai, India in 1987 and his Masters and Doctorate degrees in Chemical Engineering from Worcester Polytechnic Institute, Worcester, MA. He has over 17 years’ experience working in the Biotech Industry in process development, process scale up, manufacturing and facility / equipment design for over 30 biologics products derived from either mammalian or microbial cultures. He has previously worked at BioChem Pharma, Dow Chemicals, GlaxoSmithKline and Amgen. In his current role as Director, Manufacturing Sciences and Technology at Lonza Biologics, Portsmouth, NH and Hopkinton, MA he manages a group of 50 scientists and engineers responsible for process transfer and scale up, process characterization, manufacturing and regulatory support. His hobbies include hiking, biking and coaching youth basketball.

Judy Bodette, Deputy Director of Process Engineering, Sanofi Pasteur
Judy Bodette received her Bachelor’s of Engineering in Chemical Engineering from Northeastern University in 1988. She has over 17 years experience working in the Pharmaceutical and Biotech Industry, in facility and equipment design as well as process engineering. She has previously worked at Badger Engineers Inc and Process Facilities Inc. In her current role as Deputy Director of Process Engineering at Sanofi Pasteur, Canton, MA (formerly Acambis, Inc.) she is responsible for process engineering projects to support live viral vaccine production, as well as facility and equipment design.

Anton R. Edmund, Ph.D.
Dr. Edmund has more than 15 years of Bioprocess Engineering and management experience in Biopharmaceutical and medical device industries. Dr. Edmund earned his PhD (Biomedical Engineering), MS (Biomedical engineering and Biotechnology), and BS (Biotechnology) from University of Massachusetts at Lowell. Dr. Edmund worked at Genzyme, a leading bio-pharmaceutical company, for more than 14 years where he proved success in managing complex projects especially startup upstream & downstream operations, and implemented numerous process improvements. Dr. Edmund has an extensive experience in mammalian and microbial cell cultures. Additionally, Dr. Edmund serves as a president at applied bioinformatics consulting firm

Christian Lim, Process Engineer and Project Manager, CRB
Christian is a process engineer and project manager with over ten years’ experience in the biopharmaceutical and vaccine manufacturing industries. He has a broad knowledge of engineering design, manufacturing processes and regulatory requirements. He has participated in the basis of design, process modeling simulations, equipment design and selection, acceptance testing, commissioning, and validation. In addition, Christian has successfully led, managed, and scheduled large capital engineering projects and facility start-up operations. He has earned a Green Belt in Lean Six Sigma for operational excellence and supply chain management. Prior to joining CRB, Christian has worked for Johnson & Johnson, Amgen, Wyeth Biotech, Pfizer, and Genzyme

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before 05/03/2012:
Members $50
Non Members $95*
Student Members $5

After 05/03/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

1 May 2012
CPIP Study Group-Session 7

This is Session 7 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

1 May 2012 -
2 May 2012
ISPE INTERPHEX Bus

Traveling to INTERPHEX from the Boston area? Sign up for a Complimentary Roundtrip Shuttle Bus.

Buses will depart Boston on May 1 and 2 at 7am. Return trip departs from the Jacob K. Javits Center in NYC at 6pm on May 1 and 4:30pm on May 2. Take a one-day bus or stay over night.

Pick-up Location: The Rt 128 Parking Lot at Blue Hill Dr & University Avenue Westwood, MA.

NOTE: please disregard any reference to "seminars" or "seminar selection." We had to modify our seminar registration to accept bus reservations. You must select a bus trip below. Thank you.

28 April 2012
ISPE CEO Free Throw Sponsor at Bio-Ball

Join us again this year!

Bio-Ball is a unique and exciting opportunity for biotechnology companies of Massachusetts to reap the rewards of volunteerism and invest in the community by sponsoring and staffing a special kind of March Madness. The marriage of the Massachusetts biotechnology industry and Special Olympics Massachusetts centers on a shared goal: the promise of a better tomorrow. While biotechnology companies strive to discover and create the innovations that will make for a healthier future, Special Olympics Massachusetts is dedicated to empowering individuals with intellectual disabilities and other closely related disabilities by giving them opportunities to develop physical fitness, demonstrate courage and participate in a brighter tomorrow. In addition to the synergies between the two organizations, volunteers at Bio-Ball have the unique opportunity to interact with the very beneficiaries of the event itself. The Massachusetts biotechnology industry is making the promise of a better tomorrow a reality by pursuing cures for many of the illnesses and disabilities that affect these athletes. In turn, the resilience of these athletes reminds us all in the biotechnology community why we strive so hard as an industry to persevere and fight to realize our goals of curing disease. For more information on Special Olympics Massachusetts, visit their website here

24 April 2012
CPIP Study Group-Session 6

This is Session 6 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

19 April 2012
ISPE Documentation Surrounding GMP Facilities and Processes: The Real (and Sometimes Not-So-Real) Expectations

PROGRAM SUMMARY:
The Time, Money, Value, Quality, Safety. These variables all describe the amount of documentation required when specifying, engineering, building, and operating GMP facilities. This program will investigate and provide open forum discussions on what each department involved in delivering and operating quality systems for GMP facilities expects as the minimum documentation requirements and why. In doing so, we will investigate the blurring lines between commissioning and qualification. We will also look at the real value that comes from spending countless hours developing, reviewing, and final approval cycles of the finished document and possible ways to remediate the process. 

The program is designed to provide insight to all members of the delivery and operations team including operations, manufacturing, quality, validation, and vendors.

PANELISTS:
Chris Ames, Director Quality Assurance Validation, Genzyme
Chris Ames is currently the Director of Quality Assurance Validation for Genzyme Allston joining in September 2011.  His group is responsible for the QA oversight for all validation activities on the site. Previously, Chris held corporate Validation Director roles at both Hospira and Catalent Pharma Solutions. His experience covers more than 20 years in quality and validation starting as a Validation Engineer and progressing through roles of increasing responsibilities at Schering Plough and Hoffman la Roche before moving to Catalent Pharma Solutions.

Rob Beane, Regional Manager - Compliance, IPS (Integrated Project Services)
Rob has over 14 years of experience in managing and leading commissioning and qualification efforts in the pharmaceutical, biotechnology, and medical device industries. Mr. Beane has experience in validation planning, project management, automation validation, computer system validation and process validation, and is currently serving as Regional Manager, Compliance for Integrated Project Services (IPS). Rob has assisted clients with the implementation of science and risk-based approaches to compliance to align with the ISPE Baseline Guide for Commissioning and Qualification and ASTM Standard E2500, including compliance projects up to a budget of $5MM. Rob is a member of ISPE and PMI.

Mike Marino, Sr. Quality Engineer Corporate Quality Systems, Boston Scientific
Mike is a Project Manager within the Global Facilities Organization for Boston Scientific with 25 years in both Facilities system design and Quality Assurance for GMP manufacturing (pharma and device). Mike is the Corporate SME for BSC’s Controlled Environment manufacturing qualifications. In this role Mike is responsible for all Commissioning and Qualifications on new construction and renovation projects for Corporate Facilities. Specifically clean manufacturing suites and controlled environments, sterilization facilities, and warehouse and distribution centers. His responsibilities include providing the corporate guidance in quality systems regulations (QSR) and compliance to the site’s project teams, manage commissioning consultants, plus integrate the Quality Systems to Facilities projects. He is also responsible for adherence to agency regulatory requirements, ISO standards and guidance’s to the commissioning and validation of critical utilities systems. Mike serves on a corporate committee for ISO review and standards implementation.

Dave Mitchell, Senior QA/QC Lead, Cotter Brothers Corp
Dave and is a current AWS (CWI) Certified Welding Inspector for over five years. Dave has been responsible both directly and in support of the documentation requirements that are incorporated in all of the project Turn Over Packages supplied to end users. He has been performing inspections and supplying documentation to the Cotter Brothers Corporation for over eight years and has over ten years experience in the industry

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before 04/12/2012:
Members $50
Non Members $95*
Student Members $5

After 04/12/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information. 

14 April 2012
ISPE Student Poster Contest

This year's Student Poster Contest will be held at WPI on Saturday, April 14, 2012.  More information for this program will be available soon. If you have any questions call the office at 781-647-4773.

10 April 2012
CPIP Study Group-Session 5

This is Session 5 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

3 April 2012
CPIP Study Group-Session 4

This is Session 3 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

27 March 2012
CPIP Study Group-Session 3

This is Session 3 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

20 March 2012
ISPE Harpoon Brewery Tour and Tasting

Come join the ISPE Boston Chapter’s Young Professionals at the Harpoon Brewery for an in-depth informational session about Harpoon’s brewing processes as well as some sampling of the great beers they brew. A knowledgeable member from Harpoon will be on hand to give a history of the brewery as well as some insight to the scientific aspects of their brewing operations.

This is a great opportunity to meet other people from different areas of this exciting and diverse industry and get involved with the International Society of Pharmaceutical Engineers, all while enjoying the many beers Harpoon has to offer. Appetizers will also be available. There is free on-site parking available at the brewery.

15 March 2012
ISPE The Latest Standards in Pharmaceutical Water: We Wrote the Book

Come hear the world’s top water experts discuss the 2011 revision of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition)and how to apply it to your work. ISPE has literally written the book on pharmaceutical water and steam systems, and now we’re bringing together the Guide’s authors for an interactive look at the last 10 years of water system innovation. If you are involved in pharmaceutical water – or ever will be involved in pharmaceutical water – you can’t afford to miss this once-in-a-lifetime event!

Learn about this vitally important subject straight from the international team of experts who wrote the ISPE Baseline Guide: Water and Steam Systems (Second Edition).

Introductory track: 18.30 – 20.30
Advanced track: 15.30 – 20.30

Who should attend?
Anyone interested in learning current practices on water and steam systems, anyone preparing to defend an audit.

What you will learn?
Attendees will learn from the Guide authors about case studies and behind-the-scenes input to the baseline guide. (A review of the baseline guide is not essential, but will provide important framework for this session.)

Confirmed Speakers:

  *  Cameron Sipe – Primary author and editor, ISPE Baseline Guide: Water and Steam Systems (Second
     Edition)
  *  TC Soli – Contributing author, Water Baseline Guide
  *  Gary Zoccolante – Contributing author, Water Baseline Guide
  *  Andrew Collentro – Contributing author, Water Baseline Guide
  *  Joe Manfredi – Contributing author, Water Baseline Guide; Chair, ISPE Critical Utility Community of Practice
     (COP); Member, ISPE Critical Utilities COP Steering Committee
  *  Phil Sumner – Editor-in-Chief, ISPE Good Practice Guide: Ozone; contributing author, Water Baseline Guide
  *  Daryl Roll – Contributing author, Water Baseline Guide

Attendees will have the chance to buy the new Water and Steam Systems Baseline Guide, the newly released ISPE Good Practice Guide: Process Gases, and pre-order the upcoming ISPE Good Practice Guide: Ozone at special discount prices!

Visit www.ISPE.org/We-Wrote-the-Water-Book today to register for this unique, one-time only event! Click on "Attend the Event" in the orange box on the right hand side.
 

Thanks to our Program Sponsors:
  *  Burkert Fluid Control Systems
  *  Commissioning Agents Inc.
  *  Microtest Laboratories, Inc.
  *  Saint Gobain Performance Plastics

13 March 2012
CPIP Study Group-Session 2

This is Session 2 of the CPIP Spring Study Group. For more information on the CPIP Classes, click here.

If you have any questions, please call the office at 781-647-4773.

6 March 2012
CPIP Study Group

PROGRAM:  
The Certified Pharmaceutical Industry Professional (CPIP) certification demonstrates competence in pharmaceutical industry practices.  The study group will prepare industry professionals to qualify for CPIP certification.

Come to an informational meeting to learn more about the CPIP program and the spring study group.  Each class will run from 6pm-9pm and the cost includes all 9 sessions.  If after the informational session you choose not to continue the course, we will refund your registration fee.  

REGISTRATION FEE:
$100
This is a Members-Only Event.  If you are not yet a member of ISPE, there's no better time to join! Visit www.ispe.org/join or call (813) 960-2105 today.


SCHEDULE:

Session 1: 3/6/2012 (Free Introductory Class)

Session 2: 3/13/2012

Session 3: 3/27/2012

Session 4: 4/3/2012

Session 5: 4/10/2012

Session 6: 4/24/2012

Session 7: 5/1/2012

Session 8: 5/15/2012

Session 9: 5/22/2012

2 March 2012
ISPE Annual Ski Trip

The Chapter's Annual Ski Trip will be held on March 2, 2012 at Loon Mountain.  Space is Limited, so Don't Delay!

Price Includes:
Bus ride up and back, full day adult lift ticket, lunch voucher, and a lot of fun with fellow ISPE members!

Note: Books of 4 Tickets are available for $260.  If you would like to purchase a Book, please fill out the flyer.

Bus Departures:
5:30 AM: from Newton Marriott - Rt. 128

6:00 AM: from Chateau Restaurant - Andover, MA
7:00 AM: from LL Bean, Concord - NH

Bus Returns:
7:00 PM: to all Departure Sites (Concord, Andover, Newton)

Thanks to our Bus Sponsors:
Commissioning Agents, Inc.
GxP Automation
R.W. Sullivan Engineering
SciTech Builders
Signer Harris Architects
Superior Controls, Inc. 
UltraFiltronics

16 February 2012
ISPE Between Love and Madness Lies Obsession: Project Management in the Pharmaceutical Industry

PROGRAM:  
The effective delivery of projects within the pharmaceutical industry has rapidly become a significant metric for business performance and competitive advantage. Three critical aspects to the successful delivery of pharmaceutical projects are covered in this program. Part I provides reference to tools and best practices for the successful delivery of projects within a pharmaceutical setting by introduction to the recently published ISPE Good Practice Guide on Pharmaceutical Project Management. Part II of the program covers the role of the Project Manager - what are the true and realistic requirements of a good Project Manager and what expectations does this role have on other project team members? Part III of the program provides insight into how decisions that are made during the life cycle of a project can significantly impact business performance and ultimately determine the value created or added to the business.

This program will be beneficial to any industry professional who has exposure to, or is working within, a project based environment in the pharmaceutical industry. 

Click Here for Meeting Handouts from Keith Gibbs
Click Here for Meeting Handouts from Patrick Watters
Click Here for Meeting Handouts from Harold Engstrom 

SPEAKERS: 
Keith D. Gibbs, Yonkers Industries, Inc.
Patrick Watters, Pfizer Global Engineering   
Harold Engstrom, Innovative Process Solutions, Inc.  

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before 02/09/2012:
Members $50
Non Members $95*
Student Members $5

After 02/09/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information. 

19 January 2012
ISPE Automation - The Real Story Behind the Curtain

PROGRAM:  
There has been much interest in the black box of automation. This program will give insight to the basics of automation found in the pharmaceutical industry and the challenges that we face making the black box operate.
Since critical automation of a pharmaceutical facility involves both HVAC and process control, the program will provide insight into both. Attendees will gain a basic understanding of HVAC theory of operation as well as a basic understanding of efficient design of process automation systems allowing them to appreciate and understand what it takes from all team members to provide automation systems that will produce quality and consistent product research and production.

Click Here for Meeting Handouts from Jay Zaino
Click Here for Meeting Handouts from Doug Brenner 

SPEAKERS: 
Jay Zaino, GxP Automation, LLC
Doug Brenner, Superior Controls Inc. 

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before 01/12/2012:
Members $50
Non Members $95*
Student Members $5

After 01/12/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information. 

THANK YOU TO OUR PROGRAM SPONSOR:
RoviSys

12 January 2012
ISPE Annual New Year's Social

Come Celebrate the New Year's Season with Friends and Colleagues!

Flat Top Johnny's, One Kendall Square, Cambridge, MA

15 December 2011
ISPE Integrated Commissioning and Qualification: Saving Time and Money Without Compromising Quality

PROGRAM:  Use of Integrated Commissioning and Qualification models based on ASTM E2500 offers a rare opportunity – a chance to deliver projects that meet user and product needs, with the full documentation package required by regulatory authorities, and do it on time and within budget. However, having your cake and eating it too requires a departure from the traditional approach. This evening’s program will lay out a series of C&Q models, explain how they work (or do not work) and use first hand case studies to highlight the benefits and risks of each. This workshop will be presented in two parts, the first will be a presentation of various models and chronicle their history and the second will address how to set up integrated C&Q programs. Bring your questions and do not hesitate to interrupt in this interactive workshop!

 Click here for the 12/15/2011 Handouts

SPEAKER: Jack E. Greene

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:

Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

15 November 2011
ISPE Pharmacogenomics: What the Future Holds for Us!

Pharmacogenomics: The future of clinical trials, new product development and the practice of medicine

WHO SHOULD ATTEND: Pharmaceutical Company to Doctor to Patient or anyone in between. Pharmacogenomics is the study of how an individual's genetic inheritance affects the body's response to drugs. Hear how the future may hold the promise that drugs might one day be tailor-made for individuals and adapted to each person's own genetic makeup. In this interactive workshop, Michael Drues will present where we are today and what people are already thinking about.

PRESENTATION: Pharmacogenomics, also known as personalized medicine, has received increased attention in recent years.  But what is pharmacogenomics and it really a new idea?  This presentation will focus on:

*  What is pharmacogenomics?  Is it really a new idea?
*  How will pharmacogenomics impact the way we do clinical trials?
*  How will pharmacogenomics affect new product development?
*  How will pharmacogenomics change the way we practice medicine?
*  Other interesting issues to ponder (time permitting)

During this interactive workshop, participants will be exposed to multiple examples of pharmacogenomics applications currently on the market, under development and on the drawing board.

SPEAKER: Michael Drues, Ph.D. Vascular Sciences

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:

Members $60
Non Members $115*
Student Members $10

*Join ISPE within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate!

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

17 October 2011
ISPE 9th Annual Golf Tournament

Please note: This is the new date for the Golf Tournament due to the weather on 8/15/2011. The tournament is still currently sold out.

This year, the Chapter will hold its Annual Golf Tournament at a new location!
Click here to view the Indian Pond Country Club

Schedule:
7:30-8:30 AM - Registration and Continental Breakfast
8:30 AM - Shotgun Start - Scramble Format
1:30-3:30 PM - Reception/Cocktails/Buffet Lunch

5 October 2011
ISPE 20th Annual Product Show and Educational Seminars

ISPE Product Show - Morning Educational Sessions, hear the Keynote Address and visit over 300 exhibitors in the afternoon Show Floor from noon to 7:30 pm. Jonathan Kraft, President, The Kraft Group, to deliver this year's Keynote Address. Plan your day using the schedule below. 

Click here for full educational program descriptions.

Also new this year, attend the Product Show and pick-up a free wristband from an exhibitor to attend the After-Party Networking Reception at CBS Scene. Scheduled to appear is Jerod Mayo, New England Patriot Linebacker. Don't miss this opportunity to meet Mayo and get an autograph signed!

SCHEDULE:
Educational Seminars: 9:00 am to 12:00 pm
Attendee Lunch SOLD OUT
Exhibitor Show Floor: 12:00 pm to 7:30 pm
Keynote Address: 3:30 pm to 4:45 pm
After Show Networking Reception: 7:30 pm to 9:30 pm

* The 20th Annual Product Show and Educational Sessions are FREE to attend. The Lunch and Patriot Hall Tour are Sold out. 

29 September 2011
ISPE Young Professionals Annual Boat Cruise

Come join the ISPE Boston Area Chapter, Young Professionals for our kick-off event of the season! New and returning Members are welcome to enjoy in a night of appetizers, socializing, and networking as we tour the Boston waters.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. Hosted by the Boston Belle Charter Company- this is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE.

Registration Fees:
Before 9/22
Members: $20 and Non-Members $25

After 9/22
Members: $30 and Non-Members $35

 

14 September 2011
ISPE Whats Next in Risk Management: Human Factors and Root Cause Analysis

Risk Management is more than performing a one-time risk assessment; it is about imbedding it within the product and process lifecycle. This evening’s program spotlights its use at two different points along the life cycle, in equipment design, and in manufacturing. Please join your fellow colleagues in learning how to better use risk management in the exciting field of Human Factors and the important Root Cause Analysis process.

PRESENTATION ONE:
Investigating the Problem: Use of Risk Management in CAPA Root Cause Analysis
Susan Reilly 

PRESENTATION TWO:
Mitigating Pharma Equipment Risk Through Human Factors 
Christina Mendat, PhD

Click here for the 9/14/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Members $60

Non Members $115
Student Members $10

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

8 September 2011
ISPE Product Show Training Camp: How to Make October 5th Easy, Fun, and Profitable!

PROGRAM:
Want to get the most out of your Product Show experience? Do you see other companies breezing in and out of Gillette and wonder how they do it? This informative session will take you from pre-Show marketing, to display best practices, materials load-in, trade show etiquette and a tour of Gillette Stadium that will Show you the quickest way to get around. Hear from Product Show veterans, Gillette Stadium representative and SER Expo personnel.

Who Should Attend:
*
Any Pre-Registered Exhibitors
* First Time Exhibitors
* Anyone that wants to get the most out of their Product Show experience!

PROGRAM SCHEDULE:
1:30 – 2:30 PM           Registration and Networking Reception
2:30 – 4:00 PM           Program, Q&A
4:00 – 5:00 PM           Tour of Loading Docks and Show Floor, Wrap-up and Final Q&A 

REGISTRATION FEES:       
1st Company Attendee           $25
2nd Company Attendee          FREE

Pre-Registration is closed, but walk-ins will be accepted at the door. 
If you have any questions, call the office at 781-647-4773.

30 June 2011
ISPE Social - It's Five O'Clock Somewhere

The International Society for Parrothead Engineering - Boston Area Chapter Social Committee invites you to their Summer Social, “It’s Five O’Clock Somewhere”, on June 30th, featuring the Cocabanana Band.  With songs from Jimmy Buffett and Latin rhythms, a small bit of the Caribbean will be created on the roof top of the Baseball Tavern in Boston overlooking the great Fenway Park, No game this night so parking is available and cheap, plus it’s walking distance to the T.

There will be prizes for the best Parrothead costume, a Limbo competition, and a toy drive to benefit the Children’s Hospital Boston.

And of course, sandals and sunglasses are highly recommended! For the Summer Social flyer and donation information, click here.

16 June 2011
ISPE Streamlining Extractables & Leachables Data: YES! Someone HAS Done This Before, and We Have the Data to Prove It!

Do you find yourself being asked to provide leachables and extractables data, and wondering where to begin? Learn how to share data and knowledge with other industry professionals to save valuable time and resources, and allow yourself to focus on your process.

The Extractables and Leachables Safety Information Exchange (ELSIE) is a consortium of pharmaceutical, biotech, and medical device companies that is developing a database that will hold (i) safety information on extractables and leachables from a variety of materials; and (ii) controlled extraction study information from materials used in container closure systems, devices, and bioprocessing. The ELSIE database offers a number of valuable potential benefits including reducing duplicative safety studies, streamlining the search for safety information for extractables and leachables. It also provides E & L information that companies can use early in their development, to reduce the risk of resource-draining leachables issues arising at the end of development. Ultimately this will help companies deliver high quality drug products to patients in a timely manner. During the ISPE seminar, ELSIE representatives will provide background on leachables and extractables, review the consortium's key priorities and recent progress, and demonstrate the Safety Information Database.

MEMBERS ONLY TOUR (45-minutes): The 460,000 square foot main building at Abbott Bioresearch Center houses biopharmaceutical research and production. See key areas related to the multi-product production facility; including, the first floor utility area to view pure water systems, chillers, boilers and water treatment, and a neutral corridor (minimal gowning) view into clean room production areas (cell culture, purification and glass wash).

SPEAKERS:
William P. Beierschmitt, PhD, DABT
Dr. Arthur Shaw

Click here for the 6/16/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 4:45 pm to 6:30 pm
Members Only Tour of Abbott Bioresearch Center
Program: 6:30 pm to 8:30 pm

REGISTRATION FEES:
Members $60
Non Members $115
Student Members $10
 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Waters Corporation
Worcester Polytechnic Institute

8 June 2011
ISPE Young Professionals Craft Beer Tasting Social

Come join the ISPE Boston Chapter’s Young Professionals for a night of craft beer tasting, appetizers, socializing, and networking. We will have our own private function room with fifteen craft beers open for tasting and three of Gordon’s beer experts to discuss the beers.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. This is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the International Society of Pharmaceutical Engineers, all while enjoying delicious craft beers from around the world.

Registration Fees:

Members: $20
Non-Members: $25

19 May 2011
ISPE Process Scale-up & Technology Transfer - Beyond E. coli and CHO: Case Studies in Alternative Host Platforms

PROGRAM:
We are delighted to present two lectures focusing on the challenges and successes of process scale-up and technology transfer of biopharmaceutical manufacturing processes that use emerging, novel production host organisms.  Our speakers have participated in the development of cutting edge production technologies that provide new, robust alternatives to the biotechnology industry.  They will provide an overview of the benefits of the following novel technologies followed by case studies:

     * Pseudomonas fluorescens developed by Pfenex, and
     * PER.C6® human cell lines developed by Percivia.

SPEAKERS:
Lawrence Chew, Ph.D., Director of Fermentation Development, Pfenex
Rachel Hoff, Associate Scientist, Upstream Process Development Group, Percivia
Anna Tchoudakova, Ph.D., Scientist, Cell Line Developement Group. Percivia

Click here for the 5/19/2011 Handouts

MODERATOR:
Susan Dana Jones, Ph.D., VP and Senior Consultant, BioProcess Technology Consultants

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before May 12th
Members $50
Non Members $95
Student Members $5

After May 12th
Members $60
Non Members $115
Student Members $10
 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Waters Corporation
Worcester Polytechnic Institute

21 April 2011
ISPE Talking Shop: A Round Table Discussion of Lessons Learned on Skid Based Process Equipment

It's a black box, right? OK, it's a stainless steel, skid mounted process system. It is shiny, has lots of pipes, instruments and equipment, cost a lot of money, but it may not work exactly the way you want it to work. Come to this highly interactive session to share and learn about how these skid based process systems go from the drawing board to the production environment.

The Boston Area Chapter of ISPE has assembled subject matter experts who have lived through all steps of the process from conceptualization to operation and will share their experiences through our interactive "talking shop" series. Bring your questions, comments, and experiences to share with the group and be ready to participate.

The program has been broken into three segments, with each having a short presentation followed by a peer to peer open discussion.

Part 1: Design considerations, engineering, determining user requirements, and producing a functional requirement specification.
Part 2: Buy out of the equipment, terms and conditions, fabrication, factory visits and factory acceptance testing.
Part 3: Installation, startup, and commissioning of the system.

SPEAKERS:
Experts Rich MacLean from Biogen Idec, Ron Berk from Hyde Engineering and Ray Foley from Parsons will cover all the bases and will be ready to answer any questions you have. The session will be moderated by Niall Johnson, past president of the Boston Area Chapter. 

Click here for the 4/21/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before April 14th
Members $50
Non Members $95
Student Members $5

After April 14th
Members $60
Non Members $115
Student Members $10
 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Worcester Polytechnic Institute

6 April 2011
ISPE Principles of Clean-In-Place Design and Cycle Development

The ISPE Boston Young Professionals are hosting this educational and social event for students, young professionals and anyone else interested in learning about Clean-In-Place (CIP) systems. The ISPE Young Professionals group was formed to foster the ideas and professional needs of individuals who are establishing their careers in the biotechnology and pharmaceutical industry. The primary focus of this group is education, career/professional development, and networking.

Pre-Registration is now closed. We will accept walk-ins. If you have any questions, please call the office at 781-647-4773.

PRESENTATION:
This seminar will give all participants a general overview of the requirements for developing a successful CIP system and cycle. The first portion of the presentation will focus on CIP basics, including designing and building a CIP system and the critical process parameters and quality attributes associated with CIP systems. During the second portion of the seminar the audience will walk through the development of a CIP cycle.

SPEAKER:
Lou Traglia is a senior project manager for Commissioning Agents Inc. (CAI). 

SCHEDULE:
Registration and Networking Reception: 6:00 pm to 6:30 pm
Presentation: 6:30 pm to 8:30 pm

REGISTRATION FEES:
Before March 30th
Members $20
Non Members $30
Student Members $5

After March 30th
Members $25
Non Members $35
Student Members $10

2 April 2011
ISPE Northeast Regional Student Leadership Career Forum

Discover the latest information on hiring trends, skills required and other tips to help you obtain a career in the pharmaceutical, biotech and medical device industry.

A full day workshop for students providing insights on careers in the pharmaceutical, biotech and manufacturing industry where an exchange of information, ideas and lessons learned can be shared among attendees.  Some key items highlighted include resume reviews by mentors, interviewing skills, professional etiquette, and networking skills.

The event will begin at 7:30 AM and conclude at 5:00 PM.

Lunch and refreshments during breaks will be served.

There will be a $25 charge for the event.

Presented by:
Boston Area Chapter
Delaware Valley Chapter
New Jersey Chapter
New England Chapter

29 March 2011 -
30 March 2011
ISPE INTERPHEX Bus

Registration is now closed. If you have any questions, please call the ISPE Boston Office at 781-647-4773. Thank you.

Traveling to INTERPHEX from the Boston area? Sign up for a Complimentary Roundtrip Shuttle Bus.

Buses will depart Boston on March 29 and 30 at 7am. Return trip departs from the Jacob K. Javits Center in NYC at 6pm on March 29 and 4pm on March 30. Take a one-day bus or stay over night.

Pick-up Location: The Rt 128 Parking Lot at Blue Hill Dr & University Avenue Westwood, MA.

NOTE: please disregard any reference to "seminars" or "seminar selection." We had to modify our seminar registration to accept bus reservations. You must select a bus trip below. Thank you.

26 March 2011
ISPE Bio-Ball Tournament

The ISPE Boston Area Chapter is once again a proud sponsor of Bio-Ball – a one-day basketball tournament and Special Olympics fundraiser which brings together teams from participating biopharma companies and partners them with Special Olympics athletes.

24 March 2011
ISPE Brainstorming Session

Brainstorming Session to plan educational content for the 2011-2012 programming season.

4 March 2011
ISPE Annual Ski Trip
Cannon Mountain, Fanconia, New Hampshire
17 February 2011
ISPE Panel Discussion: Practical Risk-Based Commissioning & Qualification

SPEAKERS:
Michelle Whipple, Associate Director of QA Validation, Bristol Myers-Squibb
Click here for handouts

Armen Nahabedian, Director, Commissioning/Qualification, Pfizer Global Engineering
Click here for handouts

Eric Felz, Validation Manager, Genzyme Corporation
Click here for handouts

9 February 2011
ISPE Career Transformations: Capitalizing on Your Transferrable Skills

SPEAKERS:
Suzanne Gray: The Entrepreneur's Source
Peter L. Antoinette: Nanocomp Technologies
Dr. Elizabeth Higgins: GlycoSolutions Corporation
Michelle Connor: AdviCoach
Fred Nothnagel: WIND (Wednesday Is Networking Day)
Shelly Henderson: Life Sciences Business Development
Christine Gebski: LIFE Technologies

20 January 2011
ISPE Dual-track Seminar on Process Automation & Control

SPEAKERS:
Tim Alosi, New England Controls, Inc.
Joe Kauten, Lonza Biologics, Inc.
James Heimbach, Lonza Biologics, Inc. 

Click here for Tim Alosi's Presentation

13 January 2011
ISPE Annual New Year's Social

Flat Top Johnny's, One Kendall Square, Cambridge, MA

Charitable Organization: Helping Our Troops (H.O.T.)
Adopt-A-Box Program
 

15 December 2010
ISPE Boston Celebration Social!

For the second year in a row, ISPE Boston Area Chapter wins the Platinum Grand Award for Excellence and Innovation

14 December 2010
CPIP Study Group

The Certified Pharmaceutical Industry Professional™ (CPIP™) Study Group

Schedule: Study classes start on Tuesday, December 7th and will run from 6 to 9 pm. The sessions will follow on 12/14, 12/21, 1/4, 1/11, 1/18, 2/1, 2/8, 2/15, 3/1, and 3/8. These dates will lead up to, and help prepare for, the spring exam period March 7 – April 15.

9 December 2010
ISPE Panel Discussion: Hot Topics in High Purity Water and Plant Tour: EMD Seronos Sustainable Facility

PANELISTS:
Anthony C. Bevilacqua, Ph.D., Mettler-Toledo Thornton
Christopher S. Corsetti, Genzyme Corporation
Bob Livingston, Arion Water, Inc.
Rick Kotosky, P.E., Organogenesis, Inc.

MODERATOR:
Brian Hagopian, Independent Consultant

7 December 2010
ISPE Young Professionals' Winter Social

Flat Top Johnny's, One Kendall Square, Building 200, Cambridge MA

7 December 2010
CPIP Study Group

To register: Please email the office at ispe@camihq.com

Location: Genzyme Corporation, 49 New York Avenue (the new Genzyme Science Center), Framingham, Massachusetts 01701

Group Leaders: Joyce Chiu, CPIP, Allan MacDonald, CPIP, John Spohn

17 November 2010
ISPE Principles of Chromatographic Protein Separation and Project Management

SPEAKERS:
Dr. Angela Lewandowski, Process Scientist, Genzyme
Niall Johnson, Owner, Johnson Project Consulting LLC - Click here for Niall Johnson's Presentation

3 November 2010
ISPE Negotiation for Success

SPEAKER:
David Mark Fourman, Unify Consulting
Please click here for handouts

27 October 2010
ISPE Oktoberfest

Tommy Doyle's Pub and Restaraunt
1 Kendall Square, Cambridge, MA 02138

6 October 2010
ISPE GAMP Forum

Speakers:
Stephen Reich, Risk Management Principal, Global Quality, Pfizer
Kristin Murray, Senior Manager, Global CMC Regulatory Affairs, Pfizer
Theresa McCarthy, Past Chair, American Society of Quality Boston Section
Randy Perez, PhD, Director, IT Risk Management and Compliance, Novartis Pharmaceuticals 

6 October 2010
ISPE 19th Annual Product Show and Educational Seminars

Keynote Address: Shire HGT--An Overview of the Company, Production Platform, and What’s Ahead for the Future by Dr. Sylvie Gregoire, President, Shire HGT will deliver the Keynote Address

21 September 2010
ISPE Soft Ball Showdown: Young Professionals vs. The Seasoned Veterans

Teddy Ebersol's Red Sox Field, Embankment Rd, Boston, MA

17 September 2010
Young Professionals Boat Cruise

Boston Belle Charters, Marina Bay, 333 Victory Road Quincy, MA 02171-3111

16 September 2010
ISPE: Optimize What? A Panel Discussion on Process Optimization in the Biopharmaceutical World

Panelist:
James Blackwell, PhD, Senior Consultant, BioProcess Technology Consultants, Inc
John (Jack) Prior, ScD, Senior Director of BioProcess Engineering, Genzyme
James Dean Vogel, PE, Principal, BioProcess Facilities Services
Larry Weiner, Director of Manufacturing Engineering & Validation at Biogen Idec

The panel discussion will be moderated by Dick Priester, Principal, Strategic Facility Planning LLC

16 August 2010
ISPE Boston 8th Annual August Golf Tournament

The Chapter will hold its Annual Golf Tournament at the Ferncroft Country Club 

Schedule:
6:30-7:30 AM - Registration and Continental Breakfast
7:30 AM - Shotgun STart - Scramble Format
12:30-2:30 PM - Reception/Cocktails/Buffet Lunch

Cost:
$1,000/Foursome
Continental Breakfast, Lunch, and Golf are included for each player

 

24 June 2010
ISPE Tour and Presentation: Sustainability and Energy Management - Delivering on the Promise

LOCATION:
Millipore Corporation, 80 Ashby Road, Bedford, MA 01730

SPEAKERS:
David Newman - Senior Director, Global Sustainability, Millipore Corporation
Paul Lukitsch - WW Energy Manager - CEM / Regional Facilities, Manager Millipore Corporation

Please click here for handouts

16 June 2010
ISPE Spring Social and Volunteer Appreciation Night - Improv Magic at the Hard Rock Cafe

Hard Rock Cafe, 22-24 Clinton Street, Boston, MA
6:00 pm to 10:00 pm; Improv Show starts at 8:00 pm

11 May 2010
ISPE Single Use Technology: Approaches in Unique Facility Design, Successful Implementation & Exploring Future Growth Opportunities

SPEAKERS:
Bob Steininger, Acceleron Pharma
Paul Slaman, Shire HGT
James Vogel, Process Facilities Services, Inc.
Pharrish M. Galliher, Xcellerex, Inc.

Click here for handouts

20 April 2010
INTERPHEX Bus

13 April 2010
ISPE and MIT Professional Education Joint Program

Bridging the Gap between laboratory research and Industrial Applications

MIT Speaker:  Prof. Bernhardt L. Trout, Massachusetts Institute of Technology
Fraunhofer CMI Speaker:  Dr Anirban Chatterjee, Fraunhofer CMI

Click here for Dr. Anirban Chatterjee's handouts
Click here for Prof. Bernhardt Trout's handouts

18 March 2010
Biotech and Pharmaceutical Manufacturing Sustainability - New efficiencies and Cost Savings

SPEAKER:
David March, Rockwell Automation

Click Here for Handouts

23 February 2010
Vaporized Hydrogen Peroxide (VHP) Gaseous Decontamination: 'GREEN' Technology for the Highest Level of Microbial Control within a Pharmaceutical Facility

SPEAKERS:
Peter Harris, B & V Testing
Larry Zanko, STERIS Corporation

Click Here for Speaker Presentations

12 January 2010
Career Management Workshops joint Program with MDG

SPEAKERS:
Carol Bergeron Bergeron Associates
Linda Trowbridge Change Dynamics
Bob Vear Change Dynamics

8 December 2009
Combination Products and Convergence

Dr. Michael Drues, PhD, President, Vascular Sciences
Click Here for Speaker Presentation

1 December 2009
Platinum Grand Award for Excellence and Innovation: Celebration Social!

At the ISPE Annual Meeting in San Diego, the Boston Area Chapter was awarded the top honor, the North American/South American Affiliate Council "Platinum Grand Award for Excellence and Innovation." Help Celebrate the Success of YOUR Chapter!

3 November 2009
CEO/Executive Dinner Series

Speakers:
Don Kiepert, President & CEO, Lantheus Medical Imaging
William Dawes, Vice President, Manufacturing & Supply Chain, Lantheus Medical Imaging

11 September 2009
Young Professionals present: Friday Night Harbor Cruise

If you consider yourself a "Young Professional" then you should attend this networking event on the Boston Waterfront. This is a great opportunity to network and a chance to learn and meet the members of the newest group within ISPE Boston; the Young Professionals (YPI). The YPI purpose is to expand the participant's knowledge and professional development through education, seminars and networking.

11 June 2009
Summer Social and Volunteer Appreciation Night

Boston Beer Works, 112 Canal Street, Boston, MA 02114

19 May 2009
Young Professionals Series: Engineering Leadership and How to Influence without Authority, Panel Discussion

Click here for the speaker presentations:
Mary Viola Presentation

Sam Liggero Presentation

29 April 2009
Young Professionals Series: Biotechnology and Career Development Seminar

Speakers:
Lou Traglia, Commissioning Agents Inc.
Kevin Lynch, Shire Pharmaceuticals

21 April 2009
Strategies to Survive the Recession: Business Partnering & Contract Manufacturing

 

Presentations
Partnering with Larger Companies
Pete Latham, Co-Founder, President, BioPharm Services US
Click Here to Download the Presentation

Contract Manufacturing
Susan Dexter, Principal Consultant, BioPharm Services US
Click Here to Download the Presentation

11 March 2009
Magnetic Nanoparticles in Bioprocessing Joint Meeting with MIT, Professional Education

Speaker:
T. Alan Hatton, Massachusetts Institute of Technology

17 February 2009
ASTM E2500 Standard and Its Use in the Real World

Presentations:

Process Validation Guidance
Robert E. Chew

The Good, The Bad and The Ugly on Implementing a New Approach
Robert L. Smith Presentation

20 January 2009
LEED: The Path to Environmental Enlightenment

Presentations:

Leed Certification Overview
Susan Dieker, LEEP AP, Interior Design

Realizing the Value of LEED
Fred Doherty, Certified Energy Manager and LEED AP

18 November 2008

Keeping It Clean - Sanitary Pumps 101

Springhill Suites by Marriott
27 Andrews Parkway, Devens, MA 01434

Presentations:

Centrifugal and Positive Displacement Pumps for Hygienic Applications
Allen LeBoeuf

Peristaltic Pumps
Mark Atkinson

5 November 2008

Biotech to Bio-fuels
Gateway Center, WPI Worcester Campus

Presentations:

Gateway Park

Biofuels: Ethanol for The Future
Christopher McPhee

8 October 2008

Product Show and Seminars
Gillette Stadium
Foxborough, MA

Seminars on:

  • Automation
  • Chromatography
  • GAMP
  • Leadership
  • Mixing
  • Project Management
  • Pumps

Presentations:

Fluid Mixing in Biotech and Pharmaceutical Applications
Kevin Eisert & Susan Sargeant

Rotary Lobe Pumps: When Good Pumps Go Bad
Ron Holly

16 September 2008

Six Sigma Part II: Key to Efficient Innovation & Cost Effective Manufacturing Process

Genzyme Center
500 Kendall Street, Cambridge, MA 02142

Presentations:

North Haven Group, LLC: Design for Six Sigma The Key to Efficient Innovation

Phillip Werth: Use of Statistical Quality Control to Improve the Productivity and Quality of a Biopharmaceutical Process

18 August 2008

“Duffers Only” Golf Outing
Ferncroft Country Club
Middleton, MA
 

17 June 2008

“You want it when?!? - Insight from corporate quality and facilities on how to plan, organize, and execute the aggressive construction schedule for your GMP facility.”

Royal Sonesta, Cambridge, MA

Presentations:

Charles Pappalardo: Accelerating Advanced Infrastructure Delivery

Michael Marino, Sr. QE: Controlled Environment Commissioning and Qualification “Using a Phased Approach to meet schedule demands”

11 June 2008

Summer Social

Boston Beer Works

20 May 2008

Water Seminar: From Water 101 to Ozone Sanitization 
Tuesday, May 20, 2008
The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

Presentations:

Brian Hagopian: Water Purification 101

Bob Livingston: Best Practice for the Use of Ozone in Life Science Applications

22 April 2008

Quality vs. Engineering: A Love-Hate Relationship
Genzyme Science Center
49 New York Avenue, Framingham, Massachusetts 01701

Presentation:

If looks could kill… No work would get done
Greg Ruklic

18 March 2008

Regulatory Seminar
Biogen Idec
Cambridge, MA

11 March 2008

PlantTour
Millipore
Bedford, MA

7 March 2008

Ski Trip

13 February 2008

February 13, 2008 - Joint Meeting with MIT
Royal Sonesta
Cambridge, MA

"Continuous Improvement in Biologicals Manufacturing: An Opportunity for Process Analytical Technology"

January 15, 2008

“It’s all in the DOCS; Planning CTD/eCTD CMC Submissions”

The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

January 10, 2008

New Year’s Social
One Kendall Square, Building 200
Cambridge, MA 02139

17 October 2007

16th Annual Product Show
Gillette Stadium Clubhouse, Foxborough, MA

10-13 September 2007

2007 ISPE Boston Classroom Training Series
Focus: Isolation Technology

30 July 2007

ISPE 5th Annual Golf Tournament
Granite Links Golf Club, Quincy, MA

19 June 2007

Joint Educational program Boston Area Chapter and New England Chapter
"The End of Validation as We Know It: A Science and Risk Based Approach to Commissioning and Qualification"
Speaker: David E. Petko, P.E., Director Engineering and Design, Johnson & Johnson

Download the presentation from this event

15 May 2007

Seminar: “What’s the Deal with Stainless Steel?”

10 May 2007

Facility Tour: COTTER BROTHERS CORPORATION

March 2, 2007

Annual Ski Trip, Loon Mountain, NH

February 27, 2007

Best Practices: Commissioning and Qualification, Abbott Bioresearch Center, Worcester, MA

January 16, 2007

Six Sigma Methodology & its Application in the Bio-Pharm and Healthcare Industries, Royal Sonesta, Cambridge, MA

7 December 2006

Holiday Social and Toys for Tots Event 
Flat Top Johnny’s Billiards
One Kendall Square, Building 200
Cambridge, MA 02139

October 18, 2006

2006 ISPE Boston Pharma Product Show
Gillette Stadium Clubhouse, Foxboro, MA.

September 26, 2006

Cleaning Equipment Design, Chemistry and Operations for Pharmaceutical and Biotech, Royal Sonesta, Cambridge, MA

August 17, 2006

Golf Tournament, Granite Links, Quincy, MA

May 23, 2006

Water, water, everywhere, but nary a drop to drink, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

March 9, 2006

Nanotechnology, No Small Matter, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

March 3, 2006

ISPE Annual Ski Outing, Loon Mountain, NH

January 30, 2006

Real-Time Quality in Manufacturing and Just-in-Time Validation, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

December 7, 2005

Annual Holiday Social and Toys for Tots Event
FELT, Boston, MA

November 16, 2005

Massachusetts Biologic Laboratory Plant Tour
Mattapan, MA

October 25, 2005

Annual Product Show
Keynote Speaker - Lt. Governor Kerry Healey

September 27, 2005

Talking Shop: "That's Exactly What I Asked For, But It's Not What I Want"
Developing Better User Requirement Specifications (URS)

August 18, 2005

Golf Tournament

June 27, 2005

Talking Shop
Sterile & Aseptic Process Vial to Vial

June 28, 2005

Phoenix Controls Facility Tour

April 20, 2005

Educational Seminar
"What do you do when the lights go out?" - Critical Power and Utilities,
Location: Royal Sonesta, Cambridge, MA

March 30, 2005

Talking Shop
Tech Transfer - What's the big deal?
Location: Biogen Idec, Cambridge, MA

March 4, 2005

Annual Ski Trip, Loon Mountain, NH

Feb 10, 2005

Problems and Operational Nightmares: 10 Years Later
Royal Sonesta, Cambridge, MA

Jan 13, 2005

Taking the Risk out of Risk
The Royal Sonesta Cambridge

Dec 9, 2004

Annual Holiday Social and Toys for Tots Benefit
The West Street Grille
15 West Street, Boston, MA 02111

Nov 9, 2004

Product Show
Newton Marriott

October 19, 2004

Talking Shop: F.A.T.
Biogen Idec Cambridge
15 Cambridge Center
Cambridge, Massachusetts

Sept. 14, 2004

Utility Systems: How do you make your WFI?
The Royal Sonesta Hotel - Cambridge
5 Cambridge Parkway
Cambridge, Massachusetts

Oct. 5, 2004

Equipment Specification/JETT Workshop
The New Boston Convention Center
415 Summer Street
Boston, Massachusetts

Aug. 12, 2004

ISPE Boston Area Chapter 2nd Annual Golf Tournament
Cyprian Keyes Golf Club
284 East Temple Street
Boylston, Massachusetts

June 30, 2004

Talking Shop
Abbott BioResearch
100 Research Drive
Worcester, Massachusetts

May 13, 2004

ISPE Boston Area Chapter
Plant Tour and Educational Program
AstraZeneca R&D Boston Facility Tour

Mar 5, 2004

Annual Ski Trip
Loon Mountain, New Hampshire

Feb 17, 2004

Educational Program and Plant Tour:
Alkermes® Brickyard Square Facility

Jan 8, 2004

Educational Program: Mycoplasma Removal, and Liquid Nitrogen Filtration -- It's all about Sterility

Dec 3, 2003

Social Program: Holiday Party

Dec. 9, 2003

Lonza Tour: Commuter Series: Facilities Program and Plant Tour Pay Me Now or Pay Me

Sep 25, 2003

Educational Program: Disposable Technology

Aug 12, 2003

1st Annual ISPE Boston Area Chapter Tournament

May 1, 2003

Plant Trip to Wyeth on "Biotech and Big Pharma"

Apr 10, 2003

Contract Manufacturing

Mar 31, 2003

ISPE Boston Chapter presents workshops at INTERPHEX

Mar 7, 2003

Annual Ski Outing, Loon Mountain, New Hampshire

Feb 25, 2003

The Changing Face of Pharmaceutical High Purity Water

Jan 8, 2003

Emerging Downstream Technologies

Dec 5, 2002

Annual Holiday Party and Toys for Tots benefit

Oct 29, 2002

"Pre-Approval Inspections - Everything You wanted to Know but were Afraid to Ask"

Oct 2, 2002

Modular Construction - A Technique for accelerated project delivery for full-scale production Biotech Facilities

Page last updated: 7 December 2011