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Boston Area Chapter Current Year Events List

Event
ISPE Product Show Committee Meeting
Date: 6 January 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 8 January 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 January 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Professional Development: Tech Skills Get the Meeting, Soft Skills Get the Promotion
Date: 16 January 2014

For Handouts See Below:

http://www.ispeboston.org/files/1_andre_ispe_2014_01_16_boston_chapter_andre_walker_two.pdf 

http://www.ispeboston.org/files/4_peter_antoinette_ispe_01-16-14.pdf

http://www.ispeboston.org/files/3_fred_ispe_powerpoint_-_networking_1-16-14.pdf

http://www.ispeboston.org/files/2_kristen_ispe_powerpoint_template_august_2012_stants.pdf 

In a competitive job market, technical skills get you in the door but soft skills set you apart. Critical to career advancement, people skills will make you a valued employee and open doors to promotion and new opportunities. Whether leading a team, collaborating with colleagues, networking at professional events or interacting with a client, strong communication skills are indispensable. But how best to develop your unique skill set? Not just to achieve results, but to set you apart as a valuable employee? This interactive session will focus on and provide training for the soft skills needed for leadership, mastering the art of networking, and improving communication. Drawing from a wealth of experience in leading and developing talent, and complete with anecdotes & “case studies” from their professional history, the panelists will provide insights for boosting personal and career success for a working professional.

PANELISTS:

Peter L. Antoinette, President & Chief Executive Officer, Nanocomp Technologies, Inc.

Fred Nothnagel, Independent Career Coach & Executive Director, WIND-Networking for Connected Professionals

Kristen Stants, Director, People and Organization Capability, Biogen Idec

Andre Walker, CPIP, Director, Manufacturing Sciences, Biogen Idec 

PANELIST BIOGRAPHIES:

Peter L. Antoinette, President & Chief Executive Officer, Nanocomp Technologies, Inc.

Peter co-founded Nanocomp Technologies, Inc. in 2004, and serves as its President and Chief Executive Officer. Prior to founding Nanocomp Technologies, he was the President and CEO of Cambridge Research & Instrumentation Inc. (Woburn, MA), a photonics company, where he led the commercialization of liquid crystal based optical technologies for telecommunications and high performance molecular imaging. Previously, he spent fifteen years with Millipore Corporation (Bedford, MA) a Fortune 500 leader in separations technology, in Sales, Marketing, and as a Vice President and Divisional Manager.

Peter also is a Director of the New Hampshire High Technology Council; sits on the U.S. Army Natick Soldier Center’s Science and Technology Board; is co-Chairman of the Industrial Advisory Board for the NSF Center for High-Rate Nanomanufacturing (Boston, MA); and is a member of United States Senator Jeanne Shaheen’s Small Business Advisory Council. Peter also served on President Obama’s National Nanotechnology Advisory Panel for the President’s Council of Advisers on Science and Technology and was selected to address members of Congress, business, and academia at the National Nanotechnology Summit marking the 10th Anniversary of the nation’s Nanotechnology Initiative, in Washington, D.C. and was named a Mass High Tech Magazine All-Star for technology.  He is the holder of four patents, and co-inventor of several pending patents.

Fred Nothnagel, Independent Career Coach & Executive Director, WIND

Following careers in vocational rehabilitation, production supervision and engineering management, Fred Nothnagel found his passion – helping professionals find rewarding work 

While serving for 14 years as a Senior Career Consultant and consultant trainer at a national firm, he developed his own independent career coaching practice. Drawing on his broad industry and functional experience, Fred has provided more than 900 professionals at all levels customized career assessments, branding, resumes, interview and networking coaching, and offer negotiation services.

For 17 years he has led the WIND networking organization, where he has presented hundreds of workshops in career exploration and job search skills in addition to facilitating weekly meetings.

An oft-invited speaker, he delivered a keynote address at the 2009 national conference of the Career Resource Management Association.

Kristen Stants, Director, People and Organization Capability, Biogen Idec

Kristen Stants is Director, People and Organization Capability at Biogen Idec.  She has been with Biogen Idec for seven years, serving in various leadership capacities in Leadership Development and Talent Management.  Prior, Kristen worked as an HR consultant with Hewitt Associates, consulting across industries in the U.S. and Asia Pacific in the area of Leadership Development and Organization Effectiveness.  She holds a B.S in Psychology from the University of Oregon, a Master’s degree in Industrial and Labor Relations from Cornell University, and a Master’s degree in Communication also from Cornell University. 

Andre Walker, CPIP, Director, Manufacturing Sciences, Biogen Idec

Andre is currently Director of Manufacturing Sciences at Biogen Idec’s Biopharmaceutical Manufacturing Operation in Cambridge, Massachusetts.  Prior leadership positions within Biogen included Director, Engineering and Facilities in Hillerod, Denmark, and Director Manufacturing Engineering in Cambridge.  A chemical engineer by training, his career focus for over 30 years has been developing processes and supporting manufacturing in various industries including consumer products, medical diagnostics, and biopharmaceuticals. 

Andre is an introvert by nature, drawn to spreadsheets and solitude. He focused on technical excellence early in his career, receiving a corporate innovation award and co-inventor status on a valuable patent, but found it difficult to have impact beyond his individual efforts.  He made committed decisions in his career to find and develop the interpersonal skills he lacked, and this has enabled success in many areas including ISPE where he has served as President of the Boston Chapter, and Chairman of the International Board of Directors.

Thank You to Our Program Sponsor:
Tufts

REGISTRATION FEES:

Before 1/9/2014:

Member $50.00  
Young Professional Members $20.00 
Non-Member $60.00**
ISPE Student Members: Free to attend

After 1/9/2014:

Member: $95.00  
Young Professional Memebers $30.00
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

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ISPE New Year's Social
Date: 30 January 2014

This event is sold out.  Walk-in's will NOT be accepted on site.  Please call the office if you have any questions.  (781) 647-4773.  

Come join the ISPE Boston Area Chapter for our first social 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 taste chocolate with wine and tour the Taza Chocolate Factory!

Location:
Taza Chocolate
561 Windsor Street
Somerville, MA 02143
6:00 - 9:00 PM

Registration Fees:
Member: $10
Non-Member: $20

Thank You to Our Program Sponsors:
Commissioning Agents, Inc
CRB
GxP Automation
Perkins + Will
R. W Sullivan Engineering
Suffolk Construction Company 
UltraFiltronics

Please note that this is a limited space event, walk-ins will not be accepted on site!

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ISPE Product Show Committee Meeting
Date: 3 February 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 5 February 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Career Forum
Date: 8 February 2014

Pre-Registration for this Program is Closed. Call the Office if you have any questions 781-647-4773.

If you will be graduating in 2014-2017, come to a workshop specifically designed to help you to hone your skills and improve your chances of getting that internship, co-op, or full time position in the Life Science 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

This program is FREE for ISPE Student Members. Materials and lunch are INCLUDED.

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ISPE Board of Directors Meeting
Date: 11 February 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Program - How We Trained the FDA
Date: 20 February 2014

http://www.ispeboston.org/files/process_validation_guide-regulatory_expectations_and_best_practices_-_ispe_february_2014.pdf  

http://www.ispeboston.org/files/fda_csv_training_-_boston_ispe_presentation_-_feb_20_2014_ispe_format_mbyrd.pdf   

PROGRAM SUMMARY:
Both presentations are based on a series of half-day training session workshops that were given directly by several members of ProPharma Group’s Senior Management to FDA Inspectors and CBER Leadership within the U.S. Food and Drug Administration's headquarters in Maryland.

TOUR: Members Only

The tour will provide a look at the new addition to Johnson Matthey’s Devens facility consisting of state of the art, self-contained manufacturing suites featuring 300 gallon to 750 gallon glass lined reactors with 1000 gallon supporting vessels to the large scale chromatography system. The facility consist of research and development laboratories, Kilo laboratories, and 100 to 500 gallon glass line and Hastelloy vessels with cryogenic capabilities. The facility has the ability to handle highly potent compounds up to SafeBridge Category 4, and Controlled Substances Schedule I-IV.  It is FDA inspected, and regulatory filings are fully supported. Don’t miss out on this event!

PRESENTATION ONE:

Industry Implementation of Current Guidance and Regulation on Process Validation

This presentation covers the 2011 released U.S. guidance and regulation pertaining to Process Development/Design, Process Validation/Process Performance Qualification and Continued Process Verification. It details regulatory expectations and industry's best practices efforts to establish a Process Validation Program and the inclusion of Risk Management strategies.

Presentation topics include how industry leaders have implemented the new approach-both prospectively and retrospectively, specific successes and benefits of the new approach and the novel shifts in quality philosophies both within industry and the Agency that have facilitated successful implementations

You will learn directly:

*  What interested the FDA concerning the current state of the Guidance implementation;
*  The best practices that other companies are currently employing;
*  The points of emphasis that the FDA remarked upon.

SPEAKER:

Alfredo Canhoto, Associate Director of the Technical Solutions consulting practice at ProPharma Group

PRESENTATION TWO:

Computer System Validation

This presentation highlights practical and technical information on CSV and electronic record requirements.

The presentation will include General CSV principles, Compliance implications of electronic batch records and related manufacturing execution systems, recent issues regarding data integrity, and compliance aspects of emerging technologies such as mobile devices and cloud computing.

You will learn:

*  About CSV topics of specific interest to FDA inspectors;
*  Obtain a refresher on the regulatory basis for CSV and supporting industry best practice;
*  Approaches to assessing computerized system risk and its impact on critical data and record integrity;
*  Insights into the compliance impacts of emerging computer technologies and integrated manufacturing     system environments.

SPEAKER TWO:

Mike Byrd, Director of Computer System Validation (CSV) for ProPharma Group

SCHEDULE:

5:00 – 6:00 PM      Tour (MEMBERS ONLY)

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

6:30 – 8:30 PM      Welcome and Program

 

Thank You to Our Program Sponsor:
Tufts

REGISTRATION FEES:

Before 2/13/2014:

Member $50.00  
Young Professional Members $20.00 
Non-Member $60.00**
ISPE Student Members: Free to attend

After 2/13/2014:

Member: $95.00  
Young Professional Memebers $30.00
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

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ISPE Product Show Committee Meeting
Date: 3 March 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 5 March 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Ski Trip
Date: 7 March 2014

Registration is now closed.  If you have any questions, please call the office. 781-647-4773.

The Chapter's Annual Ski Trip will be held on March 7, 2014 at Waterville Valley.  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 $250.  If you would like to purchase a Book, please fill out the flyer and email or fax it to office@ispeboston.org or 781-647-7222.

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 Ski Trip Sponsors:

A/Z Corp
Commissioning Agents, Inc.
Gilbane
GxP Automation
Integra Company
Perkins+Will
R.W. Sullivan
Safety Partners
Sentrol
Superior Controls
Tobin Scientific
UltraFiltronics

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ISPE Board of Directors Meeting
Date: 11 March 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Boston University Informational Meeting
Date: 24 March 2014

Information:

11:00 AM at Boston University

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ISPE Student Educational Program
Date: 25 March 2014

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

PROGRAM SUMMARY:

Biogen Idec, a worldwide leader in the biopharmaceutical industry, opens the doors of its Cambridge facility for a one of a kind tour and educational program geared specifically to students. A combination employee led tours, equipment exhibitions and presentations will give attendees first-hand knowledge of how manufacturing is done at Biogen Idec 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. Choose from one of two tours, but know that space is limited so sign up today. Remember, it’s all free if you are an ISPE student member.

EDUCATIONAL PROGRAM:

Biotech 101 by Alex Cardoso, Senior Process Engineer, Biogen Idec

What goes on inside a biotech manufacturing facility? How are these lifesaving drugs actually made? What is upstream processing? What is downstream processing? ISPE’s Boston Area Chapter is bringing you the answers to these questions and much more in their Biotech 101 session. 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.

Attend One of Two Plant Tours Being Offered

Choose one of the two separate tours offered to program attendees. In the first tour, you will gown up and go inside Biogen Idec’s clean manufacturing area to see, first hand, the equipment, processes, and procedures involved in product manufacture. The second tour takes you behind the scenes and gives you a close-up look at the critical utilities required to support manufacturing at Biogen Idec. Sign up now as each tour has a limited number of spots available!

PROGRAM SCHEDULE:

1:30 – 2:00 PM     Registration &, Networking
2:00 – 3:00 PM     Presentation: Biotech 101 by Alex Cardoso
3:00 – 4:00 PM     Tour of Manufacturing Facility / Tour of Critical Utilities Plant

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 attendance at the program is FREE

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Bioprocessing Challenges: High-Titer Mammalian-Based Cell Systems
Date: 27 March 2014

Pre-Registration is now closed.  Walk-in's will be accepted on-site.  Please call the office if you have any questions.  (781) 647-4773

PROGRAM SUMMARY:

The drive to increase production of therapeutic proteins generally requires bioreactors to operate at high mammalian cell densities (>1x107 cells/mL). These cell densities have been achieved partly through optimized cell lines and improved media compositions. However, these complex cell culture suspensions have placed increased demands on both the separation (clarification) and purification operations to remove cells, cell debris, and increased levels of impurities.

Traditionally the processing of complex harvested cell culture fluid requires a large facility incurring high operating costs. This presentation will introduce the concept of process compression. Adopting the processing strategies discussed in this presentation will permit improved yields, lower operating costs, and reduced process footprint compared to conventional methods.

This presentation will highlight the latest separation and purification technologies, processing methods and engineering strategies for handling increased productivity.  Our speaker will discuss some of the scale-up challenges that accompany these technologies including ways of modifying process and facility design. An emphasis will be placed on strategies that operate within the footprint of facilities designed to handle lower-titer processes.  Case studies will be presented for various biologic systems addressing scale-up issues associated with high cell density harvest streams.  The process optimizations discussed here may be applied to both high cell density mammalian cell harvest and high impurity process intermediate streams.

SPEAKER:

Jonathan Romero, Associate Director, Biogen Idec

Jonathan Romero currently leads the Manufacturing Process Engineering group at Biogen Idec in Cambridge, Massachusetts. Dr. Romero is responsible for leading cGMP Process Engineering activities to support clinical and commercial manufacturing with focus on cell culture, dispensary, and purification operations.  He has particular expertise in the development, scale-up and transfer of separation and purification operations and disruptive technologies.  Dr. Romero graduated from Rensselaer Polytechnic Institute (RPI) with a BS in Chemical Engineering and earned his Doctorate in Chemical Engineering from the University of Delaware under the tutelage of Dr. Andrew Zydney in 2002.

PROGRAM SCHEDULE:

5:30 – 6:00 PM     Registration

6:00 – 6:30 PM     Networking Reception

6:30 – 8:00 PM     Presentations and Q & A 

REGISTRATION FEES:

Before 3/20/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00.00**
ISPE Student Members: Free to attend

After 3/20/2014: 

Member: $60.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

Thank You to Our Program Sponsors:

 

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 2 April 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Tufts University Informational Meeting
Date: 2 April 2014

Are you looking for a Job? (or a Co-op or Summer Internship?) – We have them!!

Come join Tufts and Tufts Gordon Institute alumni working in the growing life science industry, who will answer your questions and share their valuable insights, experiences, and career paths during the panel discussion:
Careers in the Life Sciences Industry

Wednesday, April 2nd
6:00 PM Sci Tech Building Room, 136 Located at Colby Street
Free Food and Drink
Open to ALL students

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ISPE Student U Mass Dartmouth Informational Meeting
Date: 4 April 2014

Location:

U Mass Dartmouth 

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ISPE Product Show Committee Meeting
Date: 7 April 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 April 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professional Series: Engineering Leadership and How to Influence without Authority
Date: 8 April 2014

Pre-registration is closed, but you can still attend and register onsite. If you have any questions, please contact the office at (781) 647-4773.

PROGRAM SUMMARY:

This program is specifically designed for young (and not so young) professionals featuring two distinguished industry veterans who have led large organizations to success, Dr. Sam Liggero and Dr. Mary Viola, from the Gordon Institute of Engineering Management, Tufts University. Sam will share his experience and insight on how to lead and motivate when the work environment is constantly changing and priorities are unclear. Mary will lead a discussion on developing strategies for influencing across departmental boundaries and cross-functionally, even when one is not in a position of authority, with a panel of young professionals from the Master of Science Engineering Management program. The program will conclude with a networking social held at Mead Hall in Cambridge, MA.

PART ONE:
Organizational Leadership: Getting Things Done in White Water
by Sam Liggero, PhD 

The Health Care industry and many other industries are in various stages of tumultuous disruption.  How does one lead and motivate people when the work environment is constantly changing and punctuated with distrust, anger and fear and priorities are unclear, misunderstood and often in flux?  In this session, the speaker will describe approaches, specific actions, and overarching principles to address this challenge.  Many of the approaches and corrective actions presented can be implemented immediately.

PART TWO:
Building Your Leadership Skills: How to Influence without Authority
by Mary Viola, PhD

As an engineer, you are trained and rewarded early in your career for solving technical problems using logic and scientific knowledge.  However, technical knowledge alone is not enough to become a leader in today's technology-driven world.  In this session, the speaker will describe strategies for influencing others across departments or within cross-functional teams, even when you are not in a position of power.  A panel of biopharmaceutical and life science engineering professionals will share their experiences with these tools and describe how this competency has helped them perform better in their jobs and position them for career advancement.

SPEAKER BIOGRAPHIES:
Sam Liggero, PhD, Professor of the Practice, Tufts Gordon Institute

Dr. Samuel H. Liggero, has spent over thirty years in the imaging industry as an executive at Polaroid Corporation. Until November 2001, he was Corporate Vice President of Research and Development for Polaroid's Instant Digital Printing division. Under Dr. Liggero's direction, Polaroid developed the groundbreaking digital printing technologies code-named Opal and Onyx. These technologies delivered very high quality thermal prints from digital files at low cost and faster than any other technology in the marketplace.

Dr. Liggero joined Polaroid in 1970 and held leadership positions in research and development, manufacturing, sales and marketing, training and education, and customer service. He is the co-inventor of Polaroid's 35 mm Instant Slide System, the founding Director of Polaroid's Applications Group and the founding Director of the Company's Customer Care Center. He also served as Corporate Vice President and Program Fellow for New Product Development, Commercial Imaging. Since leaving Polaroid, in addition to his appointment at Tufts University, Dr. Liggero has served as an Expert Witness in patent infringement litigation, and was also co-founder and CTO of AirPrint Networks. This start-up company was funded from 2004-2008. The initial product was a system that enabled mobile phones to print images and information instantly and securely, anyplace, anytime.

Dr. Liggero also teaches Digital Photography and Photoshop at the Adult Education Program in Needham. He holds a Bachelor of Science in Chemistry from Fordham University, a PhD in Physical Organic Chemistry from Georgetown University and was also a Postdoctoral Fellow at Princeton University.

Mary Viola, PhD, Director, Engineering Management Programs, Professor of the Practice, Tufts Gordon Institute

Mary Adams Viola is the Director of Engineering Management programs and Professor of the Practice at Tufts Gordon Institute. In her role, Dr. Viola is responsible for overseeing the curriculum of the engineering management programs, which aim to enable technical professionals to succeed as engineering leaders. Dr. Viola designs and delivers innovative courses in leadership, with an emphasis on innovation and working across cultures. She has taught these courses at Tufts University and at numerous corporate settings in Boston, South Korea and India.

Prior to the Gordon Institute, Dr. Viola spent twenty years at Polaroid Corp. There, as Director of R&D, she was responsible for managing new technology platforms, requiring collaboration between other technology and manufacturing firms in Asia and the US. Dr. Viola also was plant manager for worldwide chemical operations and during that time led efforts across R&D and operations to reduce the cycle time of several of its business processes. Dr. Viola studied chemical engineering and received her BS, MS and PhD from Tufts University.

PROGRAM SCHEDULE:

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

6:30 – 8:30 PM           Welcome and Program

8:45 – 10:45 PM         Social, Mead Hall, Cambridge, MA

REGISTRATION FEES:

Before 4/1/2014: 

Member $30.00  
Young Professional Members $10.00 
Non-Member $80.00**
ISPE Student Members: Free to attend

After 4/1/2014: 

Member: $40.00  
Young Professional Memebers $20.00 
Non-Member: $100.00**
ISPE Student Members: Free to attend

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

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ISPE Student Informational Meeting
Date: 11 April 2014

Come to a General Meeting and Learn How ISPE Can Help You Connect with the Local Biotech and Life Sciences Industry

Friday, April 11, 2014

2:00 PM Room # W301

Free Snacks and Drink

Don't miss this opportunity to learn more about the Boston Chapters Programs like:

$25,000 in Scholarships awarded every year
Free attendance at monthly educational programs
Tour a Working Biotech Plant Every Semester
Annual Career Forum
Annual Poster Contest
Access to Jobs, Internships, and Co-ops

This event is organized by the MCPHS University Student Chapter of the International Society for Pharmaceutical Engineering and is sponsored by the Boston Area Chapter of the International Society for Pharmaceutical Engineering (ISPE)

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ISPE Board of Directors Meeting
Date: 14 April 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Productions Systems, Single Use
Date: 16 April 2014

Save the Date!

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ISPE Student Informational Meeting
Date: 16 April 2014

Come and Learn how ISPE, a local volunteer professional society, can help you connect with the Local Biotech

and Life Sciences Industry

Wednesday, April 16th, 2014

8:00 PM - SED Room 130

Free Food and Drink

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ISPE Facility Optimization & Process Improvement - UMass Lowell
Date: 17 April 2014

Want to participate in the UMass Dartmouth program but the UMD campus is too far away? Have we got a great idea for you!

Join the Boston Area Chapter on April 17th at U Mass Lowell and be part of several ISPE firsts:

*  Participate in the first ever simulcast of a Chapter educational program. If you’ve been to our recent educational programs, you may have noticed an A/V crew. They have been working out the details to prepare the Chapter to host its first simulcast educational program.  There will be the customary networking reception followed by a live simulcast of the speaker’s presentations and opportunity to participate in the Q&A. Many thanks for the Geographic Outreach (GO) Committee for making this happen!

*  Be part of the first ever ISPE event being held at U Mass Lowell’s brand new Emerging Technology and Innovation Center. Funded in part by the Mass Life Sciences Accelerator loan program, come see UML’s brand new building.

*  In another first - the Chapter is presenting a top-notch educational program immediately following our Annual Student Poster Contest. Attendees will meet some of our best and brightest upcoming students as they present their research, with two winning posters funded to attend ISPE’s Annual Meeting. Students will have the opportunity to network with the region’s most committed professionals and experience the energy of a Boston Area Chapter event.

Like all ISPE educational programs, light food and beverage will be served.  So join us, meet some students, watch a video tour of UMD’s new MAB center and then participate in the first chapter simulcast, where you can interact with speakers at UMD.

Poster contest starts at 4:30, video tour of UMD and networking reception at 5:30, panel discussion at 6:30. Be part of another ISPE first!

PROGRAM SUMMARY:
Biological products are expanding rapidly from classic mAbs to therapeutic proteins, conjugates, cell therapies and even tissues. Production technologies are evolving rapidly from stainless steel to single use to continuous processes. These changes offer process improvement opportunities not previously possible. Optimizing a production facility to simultaneously support a range of products and technologies, under an open access management approach, to support industry, research and education required many disciplines and compromises at every stage. You will tour the new Massachusetts Accelerator for Biomanufacturing (The MAB) and hear from the design, construction, university and industry team that developed the concept as well as the building.

WHO SHOULD ATTEND:
Individuals interested in the challenges in designing and building a multi-product, multi-client facility which also must accommodate a wide range of production technologies, such as stainless steel fermentation, single use cell culture and incubated tissue regeneration, as well as those who face challenges in production that might benefit from experimentation in a GMP-like environment.

PRESENTATION:
MAB Facility: Optimization and Process Improvement Opportunities, Presentation and Panel Discussion

In the first hour, speakers will describe the collaborative origins, design, construction and trade-offs of the MAB from their distinct perspectives of the University, industry/users, design and construction teams. The stories will emphasize the facility optimization and process improvements required for this novel, open-access multi-product, multi-client facility. The second hour will feature a moderated panel discussion with audience participation. Explore the design tensions that were balanced, the organizational collaboration required and the opportunities for continued technical improvement and community engagement in the MAB’s future.

SPEAKERS (In Order of Appearance):

Mark Trusheim, Co-Bio Consulting

Mark is President of Co-Bio Consulting and Bio-manufacturing Executive in Residence at the University of Massachusetts Dartmouth and a member of the Massachusetts Bio-Manufacturing Roundtable. In 2004 as Interim President and Board Member of the Massachusetts Biotechnology Council, Mark began working with the University of Massachusetts to develop public/private collaborations as part of an integrated strategy to advance biomanufacturing. The $32M MAB is a key part of that strategy.

As an entrepreneur, Mark founded the diagnostics company Cantata Laboratories after 10 years at Monsanto/Pharmacia, culminating as Co-President and COO of Cereon Genomics, a $500M collaboration with Millennium Pharmaceuticals. He is a former Special Government Employee for the FDA’s Office of the Commissioner. Mark has degrees in Chemistry from Stanford University and Management from the MIT Sloan School of Management.

Paul Vigeant, UMass Dartmouth

Paul Vigeant is President of MAB Inc. and Assistant Chancellor for Economic Development at UMass Dartmouth. Paul has been involved in the conception and leadership of the MAB since 2004. He is also Executive Director of the SouthCoast Development Partnership.

Chris Brigham, UMass Dartmouth

Dr. Chris Brigham is an assistant Professor of Bioengineering at UMass Dartmouth. His interests are in metabolic engineering, biomanufacturing, and microbial physiology and genetics. He received his PhD in Molecular Biology and Microbiology from Tufts University School of Medicine. He then worked as a postdoctoral researcher at MIT, where he studied biomanufacturing of sustainable alternatives to petroleum products using industrially significant bacteria with engineered, optimized metabolic pathways to synthesize value

SPEAKERS Continued:

Chris Brigham, UMass Dartmouth

added products from surplus or waste carbon feedstocks. Dr. Brigham is interested in production of bio-based polymers and fuels using this type of sustainable process. He plans to utilize the MAB to teach Bioengineering students process development and control, hopefully resulting in a “win-win” for UMass Dartmouth students and the biomanufacturing community that utilize the MAB.

Steve Fitzpatrick, DPS Biometics

Dr. Stephen Fitzpatrick played a leading role in the conceptual planning and design of the Massachusetts Accelerator for Bio-manufacturing (MAB) at U. Mass Dartmouth bringing to the project over thirty years of experience in the biopharmaceutical industry. Dr. Fitzpatrick is President of DPS Biometics, a Framingham, MA based engineering, architectural and consulting company focused on the biopharmaceutical industry. DPS Biometics is the lead design firm responsible for the planning and design of the MAB. Over the years, Dr. Fitzpatrick has consulted on the engineering development of several new medicines and technical advances stemming from the biopharmaceutical industry.

Dr. Fitzpatrick holds Bachelor’s and Master’s degrees in chemical engineering and a Doctorate in biochemical engineering from the University of Manchester, UK and is recipient of the Dista Biochemical engineering prize (Manchester University) and the 1999 Presidential Green Chemistry Award from the US EPA.

Sharon Jozokos, SuffolConstruction

Sharon Jozokos is a Project Executive for Suffolk Construction with more than 24 years of experience in the construction industry. Sharon has extensive experience in the science and technology sector, having played all roles during her career ranging from field superintendent to PX on projects valued up to $200M for prestigious clients such as MassBiologics, UMass Dartmouth, Beth Israel, and MIT, to name a few. She has managed projects that have been instrumental in cancer and pharmaceutical research, development, and manufacturing.

Sharon was the construction team lead and ultimately responsible for the successful execution of the MAB project in partnership with all team members. A few of those responsibilities include identifying and managing construction milestones with the highest quality expectations, establishing and managing the construction budget, and ensuring we maintain a team approach.

Sharon holds Bachelors in Construction Management from Wentworth Institute of Technology and a MBA from Boston College. She was named Woman of the Year by Wentworth in 2013, is a past president of NAWIC (National Association of Women in Construction), elected to the Wentworth Corporation in 2010, and is currently on the board of the Giving Circle, a Suffolk employee run nonprofit foundation.

REGISTRATION FEES:

Before 4/10/2014: 

Member $20.00  
Young Professional Members $5.00 
Non-Member $45.00**
ISPE Student Members: Free to attend

After 4/10/2014: 

Member: $30.00  
Young Professional Memebers $10.00 
Non-Member: $55.00**
ISPE Student Members: Free to attend

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

Thank You To Our Program Sponsors:

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ISPE New Biomanufacturing Facility Tour - UMass Dartmouth
Date: 17 April 2014

 

See below links for handouts: 

 

 

 

 

 

http://www.ispeboston.org/files/umass__ispe_fitzpatrick_latest_upgrade_%28final_slide_show%29.pdf

 

 

 

 

http://www.ispeboston.org/files/4_mab_ispe_jozokos_v2_04_08.pdf

 

 

 

 

http://www.ispeboston.org/files/3_mab_ispe_brigham_v2_04_07_%282%29.pdf

 

 

 

 

http://www.ispeboston.org/files/1_mab_ispe_trusheim_intro_v2_04_07_%282%29.pdf

 


New Biomanufacturing Facility Tour:

The Massachusetts Accelerator for Biomanufacturing (MAB) at UMass Dartmouth

 
This is a unique opportunity to tour a brand new facility before operations begin.  The tour will include process and utility areas that will serve as a small-scale production laboratory to test new products and ideas plus optimize current processes.  The operation of this facility has the potential to have a profound impact on our state and industry for years to come.  We will then hear the story of how this unique facility was designed and built as told by the people who lived the experience from the owner’s, designer’s, and builder’s perspectives. 

 

PROGRAM SUMMARY:
Biological products are expanding rapidly from classic mAbs to therapeutic proteins, conjugates, cell therapies and even tissues. Production technologies are evolving rapidly from stainless steel to single use to continuous processes. These changes offer process improvement opportunities not previously possible. Optimizing a production facility to simultaneously support a range of products and technologies, under an open access management approach, to support industry, research and education required many disciplines and compromises at every stage. You will tour the new Massachusetts Accelerator for Biomanufacturing (The MAB) and hear from the design, construction, university and industry team that developed the concept as well as the building.

WHO SHOULD ATTEND:
Individuals interested in the challenges in designing and building a multi-product, multi-client facility which also must accommodate a wide range of production technologies, such as stainless steel fermentation, single use cell culture and incubated tissue regeneration, as well as those who face challenges in production that might benefit from experimentation in a GMP-like environment.

TOUR SCHEDULE:
Two rounds of one hour tours will be conducted. The first set of tours begins at 4:30 PM and the second set at 5:30 PM. A maximum of 60 people per round can be accommodated. Register early to get the spot you want!

Tour A: Mechanicals and Production Window View – This tour examines up close all the process utilities in the mezzanine and basement for this flexible production facility. Taking advantage of the floor to ceiling windows in a non-qualified production corridor, this tour will also provide excellent viewing of the mammalian and microbial production trains. Finally, the tour will visit the QC, warehouse and teaching labs.

Tour B: Gowned Production Suite plus Mechanicals – Beyond Tour A, this tour explores the production suites by allowing participants to suit up and enter the clean production areas. See what goes on behind the glass walls, inspect the equipment up close and see rooms such as solutions preparation, inoculum and wash/sterilization not visible from the public corridor.

Tour C: Interstitial Space Tour (ISPE Members Only) at 5:15 PM (with either A or B). Put on a hard hat and enter the interstitial space that contains all the piping and ductwork that distributes the utilities to each of the production rooms. You’ll see the complexity that benefited from a detailed 3D BIM model

PRESENTATION:
MAB Facility: Optimization and Process Improvement Opportunities, Presentation and Panel Discussion

In the first hour, speakers will describe the collaborative origins, design, construction and trade-offs of the MAB from their distinct perspectives of the University, industry/users, design and construction teams. The stories will emphasize the facility optimization and process improvements required for this novel, open-access multi-product, multi-client facility. The second hour will feature a moderated panel discussion with audience participation. Explore the design tensions that were balanced, the organizational collaboration required and the opportunities for continued technical improvement and community engagement in the MAB’s future.

SPEAKERS (In Order of Appearance):

Mark Trusheim, Co-Bio Consulting

Mark is President of Co-Bio Consulting and Bio-manufacturing Executive in Residence at the University of Massachusetts Dartmouth and a member of the Massachusetts Bio-Manufacturing Roundtable. In 2004 as Interim President and Board Member of the Massachusetts Biotechnology Council, Mark began working with the University of Massachusetts to develop public/private collaborations as part of an integrated strategy to advance biomanufacturing. The $32M MAB is a key part of that strategy.

As an entrepreneur, Mark founded the diagnostics company Cantata Laboratories after 10 years at Monsanto/Pharmacia, culminating as Co-President and COO of Cereon Genomics, a $500M collaboration with Millennium Pharmaceuticals. He is a former Special Government Employee for the FDA’s Office of the Commissioner. Mark has degrees in Chemistry from Stanford University and Management from the MIT Sloan School of Management.

Paul Vigeant, UMass Dartmouth

Paul Vigeant is President of MAB Inc. and Assistant Chancellor for Economic Development at UMass Dartmouth. Paul has been involved in the conception and leadership of the MAB since 2004. He is also Executive Director of the SouthCoast Development Partnership.

Chris Brigham, UMass Dartmouth

Dr. Chris Brigham is an assistant Professor of Bioengineering at UMass Dartmouth. His interests are in metabolic engineering, biomanufacturing, and microbial physiology and genetics. He received his PhD in Molecular Biology and Microbiology from Tufts University School of Medicine. He then worked as a postdoctoral researcher at MIT, where he studied biomanufacturing of sustainable alternatives to petroleum products using industrially significant bacteria with engineered, optimized metabolic pathways to synthesize value

SPEAKERS Continued:

Chris Brigham, UMass Dartmouth

added products from surplus or waste carbon feedstocks. Dr. Brigham is interested in production of bio-based polymers and fuels using this type of sustainable process. He plans to utilize the MAB to teach Bioengineering students process development and control, hopefully resulting in a “win-win” for UMass Dartmouth students and the biomanufacturing community that utilize the MAB.

Steve Fitzpatrick, DPS Biometics

Dr. Stephen Fitzpatrick played a leading role in the conceptual planning and design of the Massachusetts Accelerator for Bio-manufacturing (MAB) at U. Mass Dartmouth bringing to the project over thirty years of experience in the biopharmaceutical industry. Dr. Fitzpatrick is President of DPS Biometics, a Framingham, MA based engineering, architectural and consulting company focused on the biopharmaceutical industry. DPS Biometics is the lead design firm responsible for the planning and design of the MAB. Over the years, Dr. Fitzpatrick has consulted on the engineering development of several new medicines and technical advances stemming from the biopharmaceutical industry.

Dr. Fitzpatrick holds Bachelor’s and Master’s degrees in chemical engineering and a Doctorate in biochemical engineering from the University of Manchester, UK and is recipient of the Dista Biochemical engineering prize (Manchester University) and the 1999 Presidential Green Chemistry Award from the US EPA.

Sharon Jozokos, Suffolk Construction

Sharon Jozokos is a Project Executive for Suffolk Construction with more than 24 years of experience in the construction industry. Sharon has extensive experience in the science and technology sector, having played all roles during her career ranging from field superintendent to PX on projects valued up to $200M for prestigious clients such as MassBiologics, UMass Dartmouth, Beth Israel, and MIT, to name a few. She has managed projects that have been instrumental in cancer and pharmaceutical research, development, and manufacturing.

Sharon was the construction team lead and ultimately responsible for the successful execution of the MAB project in partnership with all team members. A few of those responsibilities include identifying and managing construction milestones with the highest quality expectations, establishing and managing the construction budget, and ensuring we maintain a team approach.

Sharon holds Bachelors in Construction Management from Wentworth Institute of Technology and a MBA from Boston College. She was named Woman of the Year by Wentworth in 2013, is a past president of NAWIC (National Association of Women in Construction), elected to the Wentworth Corporation in 2010, and is currently on the board of the Giving Circle, a Suffolk employee run nonprofit foundation.

REGISTRATION FEES:

Before 4/10/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00.00**
ISPE Student Members: Free to attend

After 4/10/2014: 

Member: $60.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

Thank You To Our Program Sponsors:

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ISPE Student Poster Contest
Date: 17 April 2014

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 Las Vegas, NV on October 12-15-2014. 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

There is no cost to participate but pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE.  Join ISPE at www.ispe.org/join-or-renew.

Register today!

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ISPE YP Committee Meeting
Date: 24 April 2014

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

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ISPE Spring Golf Tournament
Date: 28 April 2014

Registration is now closed. Walk-in registrations will be accepted as space permits. Please call the office at (781) 647-4773 to determine space availability.

SCHEDULE:

11:00 AM - 12:15 PM Registration and Buffet Lunch 
12:30 PM -Shotgun Start – Scramble Format 
6:00 PM - Reception/Cocktails/Buffet Dinner

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

 

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ISPE Brainstorming Session for 2015 Educational Programming
Date: 30 April 2014

The Boston Area Chapter of ISPE is holding a Brainstorming Session to plan educational content for the 2015 programming season. This is an ideal opportunity to share your ideas and help us plan programs of interest to you for the upcoming year. If you have ideas for programs, speakers, or locations, please join us to share your thoughts. A pre-session networking reception, with light dinner, will let you unwind with fellow industry professionals. Then we will focus on your ideas and suggestions. All ideas will be collated and presented to the membership via electronic survey before being finalized for the next programming season. The Committee is meeting on July 24 to coordinate volunteers to help develop these programs. Please consider volunteering for the Educational Programs Committee to make these programs come to life!

Attendance is free (we want your ideas!), so please come and help us plan and brainstorm! All you have to do is RSVP today via the website or the form below. If you have ideas but are unable to attend, please send your ideas to the office at office@ispeboston.org.

SCHEDULE:

5:30 – 6:30 pm         Networking Reception with light dinner served
6:30 – 8:30 pm         Brainstorming Session

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ISPE Product Show Committee Meeting
Date: 5 May 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 7 May 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals: Pizza, Networking, and Bowling
Date: 8 May 2014

Pre-Registration is now closed.  Walk-in's will be accepted on site.  If you have any questions please call the office.  781-647-4773

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 available). Bowling shoes will be provided and all attendees will have access to a cash bar.

Space is limited! So reserve your spot before it's too late!

6:00 pm: Pizza and Networking
7:00-9:00 pm: Bowling

Registratons Fees before 5/1/2014
Members - $20
Non-Members - $30

Registration Fees after 5/1/2014
Members - $25
Non-Members - $35

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ISPE Upstream Processing: Development and Optimization
Date: 15 May 2014

PRESENTATIONS:
 http://www.ispeboston.org/files/ispe_05_15_14_rashid_presentation.pdf

http://www.ispeboston.org/files/ispe_05_15_14_blue_sky_presentation.pdf 

PROGRAM SUMMARY:
The successful implementation of microbial and animal cell culture processes requires optimization of a number of variables. A clear understanding of cell line development, media optimization and the control of critical growth parameters assures that upstream scientists and technicians are capable and confident in their handling of these processes. This dual track program focusses on the principals of cell growth and the unit operations that facilitate the manufacturing process.

WHO SHOULD ATTEND:

• Bioprocess, automation and quality engineers
• Personnel involved in biomanufacturing facility design and construction
• Those new to biotech that want a broad understanding of upstream bioprocessing.
• Sales, service and marketing personnel who provide equipment, technical support or materials to biotech.
• Quality control and quality assurance personnel responsible for documentation generation and review.
• Those who do not have a scientific background yet wish to pursue a career in the field of biotechnology.
• Project and program managers for equipment and material vendors that serve the biotechnology industry.
• Quality assurance personnel responsible for the review of upstream process documentation.
• Technical writers responsible for generating batch records and recipes.
• Process Development associates.

TOUR SCHEDULE:
During the reception, participants are invited to tour the New Biomanufacturing Education & Training Center (BETC) at Worcester Polytechnic Institute. The BETC is a 10,000 sq. ft. facility outfitted with bench to pilot scale biomanufacturing equipment that is dedicated to providing corporate and professional educational programs to respond to the needs of the biomanufacturing industry’s workforce development efforts.

TRACK 1: Introduction to Upstream Bioprocessing
This presentation is for students and young professionals who are interested in learning how Biological products are produced and manufactured. Topics discussed will include:

• Animal cell culture vs. microbial fermentation
• Cell line generation
• Cell propagation from a frozen vial to a production reactor
• Critical growth parameters and Bioreactor / Fermenter overview
• Harvest and product recovery.

SPEAKERS:
Norman Garceau, PhD, Chief Scientific Officer at Blue Sky BioServices

Dr. Norman Garceau is the Chief Scientific Officer at Blue Sky BioServices and is responsible for overseeing all science-related activities and for ensuring that scientific excellence is at the forefront of the company. Prior to joining Blue Sky, Dr. Garceau was employed at Pfizer Global Research and Development where he served in a variety of leadership roles in spanning molecular and cellular biology, protein production, and small molecule discovery. In addition, he served on global councils for Pfizer and was responsible for overseeing a collaboration with Life Span Biosciences. Dr. Garceau holds a PhD in Biochemistry from Dartmouth College where he studied the molecular basis of circadian rhythmicity in Neurospora crassa. Subsequently, he pursued postdoctoral research at Pfizer & Dartmouth Medical School studying the molecular basis of signal transduction for members of the TNF receptor family.

Scott Gridley, PhD, Vice President of Business Development, Blue Sky BioServices

Scott Gridley is responsible for the Business Development & Sales team at Blue Sky. With over 4 years of experience in sales at Blue Sky, Scott helps drive the company's partnership strategy and sales initiatives.

Before joining Blue Sky Scott spent 5 years working in the metabolic diseases division of Sandoz Research Institute (now Novartis Institutes for BioMedical Research) where he was involved in the design, development and deployment of automated, cell-based, high- throughput screens for anti-diabetic compounds.

Scott received his doctorate from Dartmouth Medical School, Department of Microbiology and Immunology, for his work in biochemically purifying and characterizing a human protein complex (NELF) which represses RNA polymerase II transcriptional elongation and is specifically overcome by the HIV-1 Tat protein. As a postdoctoral fellow, Scott joined Dr. Gustav Lienhard’s lab in Dartmouth’s Biochemistry department. His research focused on the insulin signaling pathway and led to the identification and characterization of several novel substrates of protein kinase B (Akt).

William Hermans, Head of Cell Culture and Scale Up, Blue Sky BioServices

Bill oversees all insect and mammalian cell culture projects. Bill joined Blue Sky in 2004, bringing with him nearly a decade of experience from Pfizer’s core service laboratory where he was one of the co-inventors of the BIIC and TIPs technologies.   Over the last ten years, Bill and his staff have significantly augmented research- scale bioreactor cell culture capacity to 200-300L/month and implemented leading edge technologies (IKM) that dramatically improve the productivity of insect cell expression services. Bill received his BS in biology from Rhode Island College.

TRACK 2: Advanced Topics for Upstream Bioprocessing
This presentation is for seasoned professionals who are interested in learning how Upstream processing of biologics can be scaled up and optimized. Topics discussed will include:

• Cell line optimization
• Media development
• Process scale up considerations
• Continuous upstream processing.

SPEAKER:
Kamal Rashid, PhD Director, WPI Biomanufacturing Education and Training Center

Dr. Kamal A. Rashid has over thirty years of academic experience in both research and biotechnology educational program development. During his career he has developed, directed and implemented biotechnology and biomanufacturing training courses at Worcester Polytechnic Institute, Utah State University, Penn State University and internationally. He joined Worcester Polytechnic Institute in 2013 to direct the newly established state-of-the-art Biomanufacturing Education and Training Center (BETC).
Dr. Rashid has delivered numerous lectures and training programs in countries, including Canada, China, The Dominican Republic, Egypt, Indonesia, Iraq, Korea, Malaysia, Philippines, Vietnam, Thailand, Taiwan, Singapore and US. Dr. Rashid is very well recognized for his continuing education, teaching and international programs. He received a national Faculty Service Award in 1997 from US University Continuing Education Association for his meritorious service to Penn State University. He was also honored in 2011 as the international professor of the year in College of Agriculture at Utah State University. His present research emphasis is on bioprocessing utilizing both microbial and mammalian cell systems. Dr. Rashid received his MSc and PhD degrees from Penn State University.

REGISTRATION FEES:

Before 5/8/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00.00**
ISPE Student Members: Free to attend

After 5/8/2014: 

Member: $60.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

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ISPE International Indianapolis Training Series
Date: 19 May 2014 - 22 May 2014

Join ISPE in May in Indianapolis and learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

 

- See more at: http://www.ispe.org/2014-training-indianapolis#sthash.7YohQVFr.dpuf

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ISPE Board of Directors Meeting
Date: 27 May 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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Young Professional's Red Sox Outing
Date: 29 May 2014

This event is sold out.  Please call the office to be put on a wait list.  781-647-4773

Come join the ISPE Boston Area Chapter Young Professionals for a fun-filled Red Sox game against the Atlanta Braves on Thursday, May 29th.  We’ll meet to pick up tickets and enjoy some social pre-game beverages at Baseball Tavern.  Availability is limited, so register today!

Registration Fee:

$20 for Members             

This event is for members only.

Limit One Ticket per Person

Schedule:

6:00 pm – Pre-Game Social

Baseball Tavern

1270 Boylston St  Boston, MA 02215

7:10 pm – Red Sox Game vs. Atlanta Braves

Fenway Park

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ISPE Product Show Committee Meeting
Date: 2 June 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2014 Season Planning Meeting
Date: 4 June 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE International Atlanta Training Series
Date: 9 June 2014 - 12 June 2014

Join ISPE in June in Atlanta and learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

 

- See more at: http://www.ispe.org/2014-atlanta-training#sthash.Eaw3nkcn.dpuf

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ISPE Board of Directors Meeting
Date: 10 June 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Scholarships Due
Date: 15 June 2014

ISPE Student Scholarships are due today!

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ISPE Risk-Based Commissioning and Qualification-Warwick, RI
Date: 19 June 2014

http://www.ispeboston.org/files/ispe_june_2014_risk_based_cq_presentation.pdf

THIS IS REGISTRATION FOR THE SIMULCAST PROGRAM IN WARWICK, RI

EVENT INFORMATION:

Attend the live program at Tufts Gordon Institute in Medford, MA or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI. The programs at both locations will include a networking reception including appetizers.

PROGRAM SUMMARY:

Industry’s latest regulations and guidances direct Lifescience companies to employ risk and science based methods to ensure that the focus of their compliance activities are directed on the elements that are most impactful to the quality, safety and integrity of their products.  These directives do not necessarily formalize a singular method to attain that end goal, outside of their focus on techniques based on science, process, product, and system knowledge.  As a result, organizations typically have their own way of interpreting the requirements, as well as their own programs and tools to complete the effort.

WHO SHOULD ATTEND:

This presentation and panel Q&A is intended for industry professionals seeking to gain a better understanding of risk management as it applies to commissioning and qualification.  The presentation will highlight the principles of the various regulatory standards available including:

ICH Q8 – Pharmaceutical Development

ICH Q9 – Quality Risk Management

ICH Q10 – Pharmaceutical Quality System

ASTM E2500 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The presentation will also cover risk management implementation strategies including real-world examples, past success stories and lessons learned.

The panel Q&A will allow for the audience to pose questions to industry experts and learn how their organizations employ risk-based approaches.  A significant portion of the session will be dedicated to audience participation. Don’t miss this timely topic!

SPEAKER:

Geoffrey von Holten has over twelve years of engineering consulting experience in the biopharmaceutical and biotech industry.  Geoff specializes in the start-up, commissioning and qualification of new manufacturing facilities. He holds a BS in Chemical Engineering from Northeastern University.

Geoff established GvH Consulting, Inc. in 2007 to focus on engineering and compliance services.  He previously worked as a project manager for Bosch Packaging Technology, where he oversaw contract validation and engineering services.  He served as the lead project engineer and validation lead for MannKind Corporation’s commercial expansion project in Danbury, CT.  He was also the process equipment commissioning team lead for Shire’s Project Atlas in Lexington, MA. 

PANEL MEMBERS:

Eric Felz, Associate Director of Validation, Shire
Eric Felz is the Associate Director of Validation at Shire, responsible for Equipment, Facility, and Utility qualification for the Alewife and Lexington Facilities.  Eric is currently involved in updating the commissioning and qualification program at Shire facilitating the effort to move to an ASTM E2500 based C&Q methodology.  Eric is involved with the ISPE Community of Practice for commissioning and qualification as part of the Owners’ Team and the Web Team.  Eric holds a BS in chemical engineering from Cornell University and an MBA from Babson College

Steve Kuzil, Associate Director Commissioning and Qualification, Genzyme
Stephen Kuzil, has over 23 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He is currently the C&Q Associate Director at Genzyme (Framingham Biologics). Recently he was with BioMerieux responsible for leading the Industrialization Engineering C&Q.  Previously he was with Stryker Biotech as the Senior Project Manager for Validation leading validation efforts for capital projects and prior to this the Associate Director for MT at Organon Teknika leading validation and manufacturing technology efforts for the site.

Michelle Whipple, Senior Manager, Validation, Baxter
Michelle Whipple, is currently the Senior Manager Validation at Baxter Healthcare Corporation, Milford, MA.  Michelle has over 18 years of experience in startup and qualification of pharmaceutical and biotech equipment and facilities.  She began her career at Genzyme at the Allston, MA facility followed by eight years within the validation group at AstraZeneca in Westborough, MA.  From 2006 to 2011, Michelle led the Bristol Myers-Squibb QA Validation group through the startup of the Devens, MA facility.

Michelle received a B.S. in Chemical Engineering from the University of Massachusetts and an M.S. in Chemical Engineering from Worcester Polytechnic Institute.  She was a member of the ISPE C&Q community of Practice (COP) Leadership team from 2006 to 2013

 

PROGRAM SCHEDULE:

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

6:30 – 8:30 PM     Presentation 

REGISTRATION FEES:

FREE TO ALL REGISTRANTS WHO ATTEND AT THE WARWICK, RI LOCATION

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

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ISPE Risk-Based Commissioning and Qualification-Medford
Date: 19 June 2014

http://www.ispeboston.org/files/ispe_june_2014_risk_based_cq_presentation.pdf

THIS IS REGISTRATION FOR THE LIVE PROGRAM IN MEDFORD, MA  

PROGRAM SUMMARY:

Industry’s latest regulations and guidances direct Lifescience companies to employ risk and science based methods to ensure that the focus of their compliance activities are directed on the elements that are most impactful to the quality, safety and integrity of their products.  These directives do not necessarily formalize a singular method to attain that end goal, outside of their focus on techniques based on science, process, product, and system knowledge.  As a result, organizations typically have their own way of interpreting the requirements, as well as their own programs and tools to complete the effort.

WHO SHOULD ATTEND:

This presentation and panel Q&A is intended for industry professionals seeking to gain a better understanding of risk management as it applies to commissioning and qualification.  The presentation will highlight the principles of the various regulatory standards available including:

ICH Q8 – Pharmaceutical Development

ICH Q9 – Quality Risk Management

ICH Q10 – Pharmaceutical Quality System

ASTM E2500 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The presentation will also cover risk management implementation strategies including real-world examples, past success stories and lessons learned.

The panel Q&A will allow for the audience to pose questions to industry experts and learn how their organizations employ risk-based approaches.  A significant portion of the session will be dedicated to audience participation. Don’t miss this timely topic!

SPEAKER:

Geoffrey von Holten has over twelve years of engineering consulting experience in the biopharmaceutical and biotech industry.  Geoff specializes in the start-up, commissioning and qualification of new manufacturing facilities. He holds a BS in Chemical Engineering from Northeastern University.

Geoff established GvH Consulting, Inc. in 2007 to focus on engineering and compliance services.  He previously worked as a project manager for Bosch Packaging Technology, where he oversaw contract validation and engineering services.  He served as the lead project engineer and validation lead for MannKind Corporation’s commercial expansion project in Danbury, CT.  He was also the process equipment commissioning team lead for Shire’s Project Atlas in Lexington, MA. 

PANEL MEMBERS:

Eric Felz, Associate Director of Validation, Shire
Eric Felz is the Associate Director of Validation at Shire, responsible for Equipment, Facility, and Utility qualification for the Alewife and Lexington Facilities.  Eric is currently involved in updating the commissioning and qualification program at Shire facilitating the effort to move to an ASTM E2500 based C&Q methodology.  Eric is involved with the ISPE Community of Practice for commissioning and qualification as part of the Owners’ Team and the Web Team.  Eric holds a BS in chemical engineering from Cornell University and an MBA from Babson College

Steve Kuzil, Associate Director Commissioning and Qualification, Genzyme
Stephen Kuzil, has over 23 years of experience in pharmaceutical and biotechnology plant commissioning, qualification, and validation. He is currently the C&Q Associate Director at Genzyme (Framingham Biologics). Recently he was with BioMerieux responsible for leading the Industrialization Engineering C&Q.  Previously he was with Stryker Biotech as the Senior Project Manager for Validation leading validation efforts for capital projects and prior to this the Associate Director for MT at Organon Teknika leading validation and manufacturing technology efforts for the site.

Michelle Whipple, Senior Manager, Validation, Baxter
Michelle Whipple, is currently the Senior Manager Validation at Baxter Healthcare Corporation, Milford, MA.  Michelle has over 18 years of experience in startup and qualification of pharmaceutical and biotech equipment and facilities.  She began her career at Genzyme at the Allston, MA facility followed by eight years within the validation group at AstraZeneca in Westborough, MA.  From 2006 to 2011, Michelle led the Bristol Myers-Squibb QA Validation group through the startup of the Devens, MA facility.

Michelle received a B.S. in Chemical Engineering from the University of Massachusetts and an M.S. in Chemical Engineering from Worcester Polytechnic Institute.  She was a member of the ISPE C&Q community of Practice (COP) Leadership team from 2006 to 2013

 

PROGRAM SCHEDULE:

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

6:30 – 8:30 PM     Presentation 

REGISTRATION FEES:

Before 6/12/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00.00**
ISPE Student Members: Free to attend

After 6/12/2014: 

Member: $60.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

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ISPE Product Show Committee Meeting
Date: 7 July 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2015 Season Planning Meeting
Date: 16 July 2014

Registration is now closed.  Walk-in's will be accepted on-site.  Please call 781-647-4773 if you have any questions.

This summer, the Boston Area Chapter will receive valuable input on educational programs of interest to our Members through a survey which was launched in June. The Educational Program Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year using the survey results. Please join us on Wednesday, July 16, 2014 as the 2015 educational season is developed.

Schedule 5:30 PM - 8:30 PM Dinner, planning the 2015 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.

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ISPE Summer Social
Date: 23 July 2014

Registration is now closed.  Walk-in's will be accepted on-site.  If you have any questions, please call the office.  781-647-4773

Register today and come join the ISPE Boston Area Chapter for our "Nantucket Breeze" Summer Social at Pier 6 in Charlestown!  We will hold a 50/50 Raffle with proceeds benefitting Heading Home.

Location:
Pier 6
1 8th Street
Charlestown, MA  02109

Registration Fees:
Member: $10
Non Member: $20

Thank You To Our Program Sponsors:
Commissioning Agents Inc.
Feldmeier 
GxP Automation
New England Lab
Perkins + Will 
R.W. Sullivan Engineering
TRG Builders
UltraFiltronics

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ISPE Product Show Committee Meeting
Date: 4 August 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 August 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Golf Tournament
Date: 18 August 2014

This event is sold out.  Please contact the office to be put on a wait list. 781-647-4773

SCHEDULE:

11:15 AM - 12:30 PM Registration and Buffet Lunch 
1:00 PM -Shotgun Start – Scramble Format 
6:00 PM - Reception/Cocktails/Buffet Dinner

To sponsor this event, click here

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

 

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ISPE Product Show Committee Meeting
Date: 25 August 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE WPI Activities Fair
Date: 27 August 2014

Location TBD

 

Save the Date!

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ISPE Young Professionals Committee
Date: 28 August 2014

This is a regular meeting for the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE WPI Activities Fair
Date: 30 August 2014

Location TBD

 

Save The Date!

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ISPE UMASS Lowell Activities Fair
Date: 2 September 2014

Location: Tsongas Center

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ISPE Educational Programs Planning Meeting
Date: 3 September 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Boston Harbor Boat Cruise
Date: 4 September 2014

Pre-Registration is now closed.  Walk-in's will be accepted on-site.  Please call the office if you have any questions.  781-647-4773

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 Massachusetts Bay Lines - 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. 

Massachusetts Bay Lines, Inc.
60 Rowes Wharf
6:00 PM - 9:30 PM
(ship leaves at 6pm sharp!)

Light Fare will be provided in the cost of registration. A cash bar will also be available 

Registration fees:    
Members:                    $25             
Non-Members:             $35

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ISPE BU Student Activities Fair
Date: 6 September 2014

Location: Nickerson Field

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ISPE Product Show Committee Meeting
Date: 8 September 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE International Philadelphia Training
Date: 8 September 2014 - 11 September 2014

Join ISPE in September in Philadelphia and learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

 

- See more at: http://www.ispe.org/2014-training-september-philadelphia#sthash.vch6Fx5Z.dpuf

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ISPE Board of Directors Meeting
Date: 9 September 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE WPI Student Meeting
Date: 9 September 2014

Time: 4PM to 5PM

Location: Salisbury Hall Room SL 115

 

See flyer for additional information

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ISPE UMass Lowell Student Meeting
Date: 10 September 2014

Time:  5:00PM to 6:00 PM

Location:  Kitson 309

 

See flyer for additional details

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ISPE UMass Amherst Student Meeting
Date: 11 September 2014

Time: 6:30-8:30 PM

Location:  Lederle Graduate Research Center, Room 201

 

See Flyer for additional details.

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ISPE Northeastern Student Meeting
Date: 16 September 2014

Hours:  7:30 – 8:30PM

Location:  Egan Building, Room 306

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ISPE MCPHS Student Meeting
Date: 17 September 2014

Room 112 Today!

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ISPE UMass Dartmouth Student Meeting
Date: 17 September 2014

Location: Textile Building, Room 102

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ISPE Good Engineering Practice, aka How to Make Friends with your Validation Group
Date: 18 September 2014

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

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

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

PROGRAM SUMMARY:
Has engineering come full circle in the biotech market over the past 30 years?  Those old enough to remember projects executed before ISPE was founded, will also remember FDA and quality groups inconsistently judging the quality of design.  ISPE has, to its credit, created many guidelines to provide a basis for best practice, but they do not necessarily address the design basis, nor level of risk

The “new” standard for engineering is risk based design.  Whether it is defined in ASTM 2500, IQH Q9, or ISPE Good Engineering Practice Guideline, the new approach is to follow a multi-step process for defining the requirements, evaluating risk, detail design, and validation/qualification. 

The intent of this program is to provide 3 different perspectives of cGEP:  the owner/drug producer, the outside engineering consultant, and the quality group that needs to justify to the regulatory authorities that the design process is robust.  After short presentations, the floor will be opened for feedback and panel comments.

PRESENTATION 1:
Maintaining Focus on GEP in a Careful Balance with Compliance

The regulated nature of the biotech industry requires that certain aspects of its facilities and systems are heavily scrutinized and documented, with Quality oversight, in order to ensure the highest degree of patient safety and product quality.  However, somewhere along the way, the focus on regulations has eclipsed the focus on Good Engineering Practice.  While it is not our intent to diminish the emphasis on regulations and, therefore, patient safety and product quality, at times our method of achieving those goals is not efficient.  By refocusing our efforts on Good Engineering Practice within the Engineering Lifecycle, in conjunction with the Regulatory requirements, we can provide a better product.  

This program will provide a venue to discuss the GEP elements of the Engineering Lifecycle, their relationship to the Regulatory requirements associated with manufacturing within our industry, and the definition of roles and responsibilities for these elements.

SPEAKER 1:
Jeanine Gigante is the Associate Director of Global Engineering and Technology for Genzyme and has 27 years of experience in process and project work in the biotechnology, chemical process and environmental fields.  She worked in the engineering design and construction field for 10 years before her 17 year tenure at Genzyme.  In that time, her experience has included the evaluation and modification of existing systems, and design of new systems for both clean and dirty utilities.  In addition to the utility systems, Jeanine has supported projects requiring the design, installation, and commissioning of new or modified process equipment and facilities for clinical operations, upstream and downstream processing, and fill/finish.  Most recently, her role has included the development and implementation of an engineering quality program, which is designed to ensure that the Genzyme engineering lifecycle incorporates Good Engineering Practice and Regulatory Compliance consistently across the corporation. 

Ms. Gigante holds a BS degree in Chemical Engineering from Northeastern University, and is a certified Project Management Professional.  She has been a longtime ISPE Member.

PRESENTATION 2:
Get Excellent Performance from Good Engineering Practice

In the past ten years the definition of Good Engineering Practice (GEP) has evolved. The focus of GEP has shifted from application of rule of thumb and compliance with the state of the art to a method ensuring that engineering endeavors provide the anticipated result. This is achieved by ensuring the scope of the project is well established, that the engineering design thoroughly addresses the project need, and all aspects of the design have a factor of safety commensurate with the level of risk.

Good Engineering Practice has also expanded to include the mechanisms for managing, documenting, and reviewing the engineering design throughout the project life cycle to ensure continued operational success.  Within regulated industries the outputs of GEP are verified and scrutinized to provide an additional level of assurance. Occasionally this review is complicated by differences of opinion about the project scope, the approach to the engineering design and the project risk assessment.  This program will provide a venue to discuss how scope, design and risk assessment can be better communicated to simplify and add value to the engineering, qualification/verification and validation project phases.

SPEAKER 2:
Howard Sneider is a Senior Process Engineer at Clark, Richardson & Biskup (CRB) Consulting Engineers. He has over fifteen 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 ISPE, Boston Chapter. Previously, he was a Senior Process Engineer at Wyeth Biotech.  He holds a BS degree in Chemical Engineering from Columbia University and an MS in Chemical Engineering from the University of Connecticut.

PRESENTATION 3:
Building Quality into GEP

Recent changes in the industry have focused validation to providing documented evidence that critical aspects for new or modified direct impact systems meet process user requirements.  Building quality into GEP provides cost effective assurance to Validate that a system’s critical aspects meet its process user requirements. This presentation will provide an overview of validations role in GEP and how it connects to regulatory audits

SPEAKER 3:
Paul Meehan is a Validation Manager at Shire and has 17 years of experience in commissioning and qualification work in the biotechnology and pharmaceutical industries.  He worked previously as an employee at AbbVie and Abbott, and prior to that as an independent contractor and with KMI/Parexel.   In that time, his experience has included managing validation personnel, participating on commissioning and qualifications team for equipment, facility, utilities, control systems and cleaning validations and defending validation reports in audits.

Mr. Meehan holds a BS degree in Mechanical Engineering from Boston University, an MBA from Boston College, and an ISPE CPIP certification.

MEETING MANAGERS:
Robert Mitchell, Robert Mitchell Engineering
Bill McCarthy, CRB Consulting Engineers 

PROGRAM SCHEDULE: Applies to both locations 
5:30 – 6:30 PM     Registration and Networking Reception
6:30 – 8:30 PM     Presentations

REGISTRATION FEES:
Before 9/11/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $60.00**
ISPE Student Members: Free to attend

After 9/11/2014: 

Member: $95.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend

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

 

Thank you to our Sponsor:

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ISPE Product Show Committee Meeting
Date: 22 September 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE BU Student Meeting
Date: 23 September 2014

Location TBD

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ISPE Middlesex Community College Student Meeting
Date: 25 September 2014

Starting a new ISPE Student Chapter!

Talbot Building Room 312 

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ISPE UCONN Student Meeting
Date: 25 September 2014

Location TBD

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ISPE Annual Product Show and Educational Seminars
Date: 1 October 2014

Click Below for Handouts to the Educational Seminars:

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

http://www.ispeboston.org/files/ispe-driving_project_success-ns_oct_1-2014_neeraj.pdf

http://www.ispeboston.org/files/harder_than_it_looks_2014_printed_r1_sm.pdf 

http://www.ispeboston.org/files/biotech_101_ispe_product_show_2014.pdf  

ISPE Annual Product Show and Educational Seminars

Although this is our 23rd Annual Product Show, this year’s event will be the first since the New England and Boston Area Chapters have become one - making it possibly our biggest and best show yet! Whether you’re attending as a vendor or an attendee, this year’s Show will provide plenty of opportunities to advance your business or career due to our expanded exhibitor area, educational sessions, career fair, vendor showcases, entertainment zone, and after party. Register today to be part of the fun! Attendance and parking are FREE.

JUST ANNOUNCEDSusan Windham-Bannister, Ph.D.,President & CEO, Massachusetts Life Sciences Center (MLSC) will give a talk at the Keynote address on "The Massachusetts Life Sciences Initiative: Building the world's leading ecosystem for life sciences innovation & growth"

Also, don't miss Michael Arnold R.Ph., Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships for Pfizer's Global Clinical Supply Chain.  In his keynote address, he will give his view of the pharmaceutical industry.

Educational Sessions: Register to attend any of the four broad-based programs.
Biotechnology: The Challenge for Tomorrow
Water Based Critical Utilities—RO, WFI, Steam:The bottom of the iceberg that makes a plant actually run!
“Harder Than It Looks”—Projects Executed Concurrently with Manufacturing Operations
Successful Project and Organizational Change through Effective Stakeholder Management

After Party: with New England Patriots Defensive End Chandler Jones at Bar Louie, Patriot Place

Schedule:
Registration Opens: 9:30 am
Keynote Address: 10:30 am to 12:00 pm
Exhibitor Show Floor: 12:00 pm to 7:30 pm
Career Center: 12:00 pm to 5:00 pm
Educational Seminars: 12:30 pm to 2:45 pm
Young Professional and Student Social: 3:00 pm to 4:00 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!

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ISPE Northeastern Student Activities Fair
Date: 2 October 2014

Location and Time TBD

 

Save the Date!

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ISPE Board of Directors Meeting
Date: 7 October 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 15 October 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 27 October 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 5 November 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 11 November 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Careers in Life Sciences
Date: 13 November 2014

Careers in Life Sciences panel discussion featuring NU graduates

 

Location TBD

 

Save the Date!

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ISPE Cloud Computing New Challenges in Data Integrity and Security
Date: 13 November 2014

Click Here for the panel presentation

EVENT INFORMATION:

View a simulcast presentation at the Crowne Plaza Providence in Warwick, RI or attend the program live at Cubist Pharmaceuticals in Lexington, MA. The programs at both locations will include a networking reception including appetizers.

PROGRAM SUMMARY:

In 2011, the FDA began their ICT21 Initiative for 21st century cloud-based computing in an effort to drive down costs and increase efficiencies. Likewise, pharmaceutical, biotechnology and medical device companies have slowly begun outsourcing some of their GxP computing needs.  Currently, there are cloud-based offerings being used within various companies in research, regulatory submissions, materials inventory, building management, labelling and recalls. Our panel of speakers will quickly review the basics of cloud computing in the life science industries, and then discuss how to meet the regulatory requirements and challenges for validation, data integrity and security.

The panel, composed of representatives from small and large Life Science organizations, will discuss the concerns, challenges, risk mitigation techniques and future of cloud computing and data integrity including:

The Current Paradigm and How We Got Here

Cloud-Based Computing - The Basics

Having Someone Else Hold Your Data - The Concerns and Challenges

Regulatory & Compliance Concerns - Data Integrity

Validation - Objectives, Strategy & Realization

FDA Perspectives on Cloud Computing & Data Integrity

The Future - What's Next?

SPEAKERS:

Tracy Lampula
Associate Director – Global Information Services (GIS) Compliance
Vertex Pharmaceuticals, Inc. 

Since joining Vertex Pharmaceuticals, Inc. in February 2003, Tracy Lampula has held multiple roles within the Global Information Services (GIS) group, including leading Computer Systems Validation and IS Governance Teams. She has led and continues to lead process improvement activities in the area of System Life Cycle (SLC), Access Management, and Change Control that support innovative implementation approaches and emerging technologies (e.g. cloud services, mobility) with a focus on GxP, SOX, and Data Privacy compliance.

Prior to joining Vertex, Ms. Lampula worked for several technology-based companies. Tracy received a BA from Clark University.

William Sanborn
Director of Information Technology,

LFB-USA, Framingham, MA

William Sanborn is the Director of Information Technology with LFB USA, Inc. Bill has 30 years of experience in IT working in several industries including manufacturing of building management technologies, industrial tagging and labeling, stationary products and Biotechnology. Most recently, Bill has held various diverse senior IT roles in the Biotechnology industry that include ERP system implementations, IT Infrastructure and support services, Manufacturing and Quality systems support, various IT Business partnership roles and the IT aspects of mergers, acquisitions and divestitures. In his current role Bill is working with LFB USA to improve efficiencies by introducing newer IT technologies to improve processes while at the same time ensuring that the business is compliant with the multitude of industry regulations.

Robert Streit
Senior Manager, Q&C Architecture and Design
Johnson & Johnson

Robert Streit is a Sr. Manager with Johnson & Johnson Quality & Compliance possessing 24 years of extensive experience in IT working with engineering, quality, manufacturing & control systems inclusive of MES. This work has included defining solutions for multiple regulated environments, developing system requirements, establishing computer systems validation plans, and creating support models for critical systems. More recently, efforts have been focused on establishing compliant approaches for emerging technologies, particularly Cloud and Mobile Technologies. More specifically, this has involved vendor evaluations and establishing supplier compliance requirements, both for assessments and contracted service agreements.

Robert J. Wherry, MSc MS CPGP CQA CPIP
Principal Consultant, Strategic Compliance Services
PAREXEL International

Bob has 30+ years of FDA-regulated industry experience with expertise in process development, process validation, computer system validation, regulatory affairs, regulatory operations, quality assurance, corporate compliance, and quality systems regulations. Bob has lectured on computer validation, biotechnology, regulatory affairs and quality assurance issues at various conferences. He has co-authored three Pharmaceutical Technology articles on computer validation and sterility assurance validation, and has contributed to the editing of several computer validation publications.

Bob holds a BS in Chemical Engineering from Lehigh University, an MSc in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde, and an MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. He also has certifications from ISPE and ASQ.  He was a Member and Vice-Chairman of the PMA/PhRMA Computer Systems Validation Sub-Committee, and is a current Member of the ISPE GAMP Americas Committee and the ISPE Boston Area Chapter Educational Programs Committee.

REGISTRATION FEES:

Before 11/6/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $60.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

After 11/6/2014: 

Member: $95.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend!
Warwick Location: FREE 

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

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ISPE International Raleigh Training
Date: 17 November 2014 - 20 November 2014

Join ISPE in November in Raleigh and learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

 

- See more at: http://www.ispe.org/2014-raleigh-training#sthash.ghKaB2ze.dpuf

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ISPE Young Professionals Committee Meeting
Date: 19 November 2014

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

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ISPE International Tampa Training
Date: 1 December 2014 - 4 December 2014

Join ISPE in December in Tampa and learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance.

Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

Courses

 

- See more at: http://www.ispe.org/2014-tampa-training#sthash.pjCqDxo5.dpuf

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ISPE Product Show Committee Meeting
Date: 1 December 2014

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 December 2014

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Social
Date: 4 December 2014

Come join the ISPE Boston Area Chapter Young Professionals at Night Shift Brewery for an evening of socializing, food, and craft beer!  Dinner will be from Square Deli in Everett, and will include a variety of sandwiches, appetizers, and salad.  Also included is a brewery tour and beer tastings.  Space is limited, so get your tickets before it’s too late! 

REGISTRATION FEES:  

by 11/27                 

Member:  $25                     
Non-member:  $35        

After 11/27  

Member: $30
Non-Member: $40

Only 40 tickets available!  Sign up today!       

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ISPE Board of Directors Meeting
Date: 9 December 2014

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE - Lean Six Sigma -Theory, Applications and Lessons Learned in the Biopharma Industry
Date: 11 December 2014

PROGRAM SUMMARY:

Every industry has their glory days defined by a time of rapid growth and unprecedented profitability leading to personal and professional advancement. And then everything changes. Work becomes, well work. Customers are more demanding. Competitors are better than ever. Management expects more work in less time and with fewer resources. Processes that seemed to work smoothly before are now surprisingly broken. Problems are everywhere and there’s no time to solve them. Everyone and everything needs to move faster. You conclude you need more resources or a different approach to leading, managing and working. You envision an environment with more problem solvers, more creativity and more participation from everyone. Enter Lean & Six Sigma, to eliminate waste, create efficiencies, reduce variation, control costs and ensure a reliable drug supply. 

Invited speakers will share several examples of how Lean - Six Sigma tools and techniques have been successfully implemented in Biopharma operations.  They will also explain the rational for impending Lean in BioPharm; and showcase a few real implementation examples. The audience will see the efficiency gains by introducing flow and problem solving tools in streamlining the process.

Limited Space Available at Lantheus!  

SPEAKERS:

Rui Coelho, Associate Director – Operational Excellence, Biogen Idec
Rui has over 25 years of management experience applying various products and process improvement approaches to product design, manufacturing operations and business processes in multiple industries. Currently he is the Associate Director of Operational Excellence at Biogen Idec. Previously he was the Master Black Belt for the Boston Scientific’s Global Six Sigma Office. He also served as Director of Quality and Six Sigma MBB for three Honeywell divisions, and Director of Quality at Black & Decker.

He is Lean Bronze Certified (SME, AME, Shingo, ASQ), an ASQ Certified Quality Manager and Quality Engineer, and a Honeywell certified Six Sigma Black Belt. Rui has an MBA from Rensselaer Polytechnic Institute concentrating in Human Resource Management, and a BS degree in Chemical and Materials Engineering from University of Connecticut.

Dan Fleming, Continuous Improvement Manager, GBMP (Shingo Prize Recipient and Examiner,
Silver Level Lean Certified)
Dan has 30 years of experience in Engineering and Operations including over 25 years of Continuous Improvement experience. He has led numerous Continuous Improvement activities on the shop floor and in support areas since 1986 and has been a speaker at regional and national conferences. Prior to becoming a Continuous Improvement Manager at GBMP in 2002, Dan was Director of Operations at United Electric Controls Company, where in 1990, he was a winner of the Shingo Prize for Excellence in Manufacturing. Dan has worked with hundreds of organizations throughout the United States including healthcare, medical device, biopharma, defense, capital equipment, food processing, contract manufacturers, machine shops, and warehouse and distribution facilities. In 2009, Dan created a highly successful Lean in Healthcare Certificate Course that has graduated hundreds of participants. Mr. Fleming holds a Bachelor’s Degree in Electrical Engineering Technology from Northeastern University.

Niranjan S Kulkarni, PhD, Sr. Operations Specialist, (Master Black Belt), CRB
Niranjan Kulkarni, PhD, leads the Operations Improvement team at CRB. In his current role as the Sr. Operations Specialist, his responsibilities include helping clients operate their facilities smarter with lower costs, greater throughputs, higher quality, greener facility and other innovative engineering solutions. He has worked with pharmaceutical, food, chemical, semiconductor / electronics assembly and packaging, manufacturing and financial industries. Dr. Kulkarni's educational background includes a Bachelor's degree in Mechanical Engineering from the University of Mumbai, a Masters in Systems Science and in Industrial Engineering, and Doctorate in Industrial Engineering from the State University of New York. He is a certified Lean Six Sigma Master Black Belt. He has numerous technical publications and has co-authored a book chapter featured in the Lecture Notes on Computer Science series. He is also a co-author of the ISPE’s Operations Management Guidance document.

REGISTRATION FEES:

Before 12/4/2014: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $60.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

After 12/4/2014: 

Member: $95.00  
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

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

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ISPE Product Show Committee Meeting
Date: 5 January 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 7 January 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 13 January 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Future Trends
Date: 15 January 2015

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ISPE New Year's Social
Date: 22 January 2015

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Flat Top Johnny's, Cambridge, MA

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ISPE Product Show Committee Meeting
Date: 2 February 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 February 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Career Workshop
Date: 7 February 2015

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ISPE Board of Directors Meeting
Date: 10 February 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Facilities
Date: 19 February 2015

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ISPE Product Show Committee Meeting
Date: 2 March 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 March 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 10 March 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Risk Based Reality
Date: 19 March 2015

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ISPE Educational Programs Planning Meeting
Date: 1 April 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 April 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 April 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE 2015 Student Poster Contest
Date: 16 April 2015

Two winning student posters, one each from the graduate and undergraduate categories will receive a $500 cash prize and a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in Philadelphia, PA. on November 8-11, 2015. 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. 

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  

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ISPE Product Show Committee Meeting
Date: 4 May 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 6 May 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 May 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Engineering and Project Management
Date: 21 May 2015

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ISPE Product Show Committee Meeting
Date: 1 June 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 June 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 9 June 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Tech Transfer: How to Manage Your Relationship with a CMO
Date: 18 June 2015

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ISPE Product Show Committee Meeting
Date: 13 July 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 July 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 16 July 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 3 August 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 5 August 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 11 August 2015 - 12 August 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 17 August 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 2 September 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 September 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 14 September 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Regulatory Compliance
Date: 17 September 2015

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ISPE Product Show Committee Meeting
Date: 28 September 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Product Show and Educational Seminars
Date: 7 October 2015

Save the Date for the 24th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 7 October 2015

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ISPE Board of Directors Meeting
Date: 13 October 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 21 October 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 November 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Soft Skill: Death by Powerpoint
Date: 12 November 2015

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ISPE Board of Directors Meeting
Date: 17 November 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 2 December 2015

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 7 December 2015

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 December 2015

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Information Systems
Date: 10 December 2015

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ISPE Annual Product Show and Educational Seminars
Date: 5 October 2016

Please note that this is the planned date for the 25th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 4 October 2017

Please note that this is the planned date for the 26th Annual Product Show!

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Page last updated: 26 June 2014