Boston Area Chapter Past Events Calendar

Pre-Registration is Closed. Walk-in registrations will be accepted on-site.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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!

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.

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.

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.

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

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

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

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.

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.

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

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!

Please note: The Members only tour portion of this event has reached capacity. If you have any questions please email office@ispeboston.org.

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.

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:       
1^st Company Attendee           $25
2^nd Company Attendee          FREE

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.

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.

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.

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.

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.

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

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.

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. 

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.

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.

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.

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.

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.

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

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.

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

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

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. 

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

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

Pre-Registration is Closed.  Walk-In Registrations will be accepted on-site.

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.

Pre-Registration is now closed. Walk-ins will be accepted on site.

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.

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

Pre-Registration has CLOSED. Walk-Ins will be accepted on-site!If you have any questions call the ISPE Office at 781-647-4773.

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. 

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

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.

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:       
1^st Company Attendee           $25
2^nd 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.

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 30^th, 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.

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

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

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

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

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

Pre-Registration for this event is Closed. We will be accepting walk-in registrations onsite. If you have any questions please call the office at 781-647-4773.

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

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.

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.

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

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

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

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

Click here for Tim Alosi's Presentation

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

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

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

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

Schedule: Study classes start on Tuesday, December 7^th 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.

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

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

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

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

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

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

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 

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

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

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

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

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

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

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

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

Click here for handouts

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

SPEAKER:
David March, Rockwell Automation

Click Here for Handouts

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

Click Here for Speaker Presentations

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

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

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!

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

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.

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

Click here for the speaker presentations:
Mary Viola Presentation

Sam Liggero Presentation

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

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

Speaker:
T. Alan Hatton, Massachusetts Institute of Technology

Presentations:

Process Validation Guidance
Robert E. Chew

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

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

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