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23rd Annual Product Show Breaks All Records

by H. Steven Kennedy, Chair, Product Show Committee, with photos by Alastair Battson Photography

Despite a rainy day, the 23rd edition of the ISPE Boston Area Chapter Product Show held at Gillette Stadium on October 1 was the place to be. Nearly 2500 people – over 200 more than the previous record – braved the inclement weather to participate in the event’s many and varied activities and made the Show a rousing success. (And if by chance you weren’t there, this short video  will give you an idea of what you missed and whet your appetite for next year.)

The wet weather produced a glittering evening scene at Gillette.

Changes to the Show’s format - many of them suggested by last year’s attendees and exhibitors – were a big success by all accounts. The major change was moving the Plenary Session to the morning. Chapter President Chris Opolski gave the State of the Chapter address reporting that the Chapter is financially sound and continues to be the largest Chapter in the world.  He reviewed our activities from the past year and highlighted ongoing initiatives: simulcast of educational programs to remote hubs throughout New England and beyond, expanded scholarship program, and continued growth of Student Chapters. Chris concluded by presenting three awards recognizing excellence within the Chapter:  

  • Volunteer of the Year Awards:  Michael Levesque and Mark Levanites
  • Outstanding Achievement Award:  Geographic Outreach (GO) Committee
  • Student Chapter of the Year Award:  UMass Lowell

Chapter President Chris Opolski opened the Plenary Session with
the State of the Chapter address and this year's Chapter Awards

Our special guest speaker, Dr. Susan Windham-Bannister, President and CEO of the Massachusetts Life Sciences Center, described the MLSC’s progress implementing a 10-year, $1-billion, state-funded life sciences investment initiative to create jobs and support advances to improve health and well-being.  She noted how ISPE has helped the MLSC attract life science companies to the area by providing the training and skills to our Members that these companies are looking for in the workforce. 

Special Guest Dr. Susan Windham-Bannister of the
Massachusetts Life Sciences Center described the vibrant
biopharma marketplace in Massachusetts.

 Dr. Michael Arnold, Sr. Director Strategic Relationships and Investigational Products Business Process Owner at Pfizer, followed Dr. Windham-Bannister with our keynote address.  Dr. Arnold is also a Member and the current Secretary of the ISPE International Board of Directors and during his address he provided a unique insight into ISPE’s future and the role the Society plays in the industry.  He was extremely impressed with the Show and the Boston Area Chapter in general and is looking forward to learning more about our best practices and how we can help other Chapters.


Keynote Speaker Dr. Michael Arnold of Pfizer provided a unique
perspective on the future of the industry and the role played
by ISPE.

The Show doors opened at noon following the Plenary Session. Attendees were then able to visit the exhibit area with its 375 booths – another Product Show record.  The new traffic flow path was well received. Attendees were able to visit all the exhibitors with ease and without the “dead” spots present in previous years.

Thousands of attendees moved through the exhibit areas with ease due to the improved layout and wider aisles.

As always, a full slate of educational programs was offered throughout the day.  The Educational Programs Committee conducted four sessions during the afternoon timeframe, all of which were very well attended (in excess of 100 each) with standing-room-only crowds:    

  • “Biotechnology: The Challenge for Tomorrow” with Dr. Kamal Rashid, 
  • “Harder Than It Looks – Projects Executed Concurrently with Manufacturing Operations” with Rick Kotosky and John Spohn, 
  • “Water Based Critical Utilities-RO, WFI, Steam: The Bottom of the Iceberg that Makes a Plant Actually Run” with Brian Hagopian, and 
  • “Successful Project and Organizational Change through Effective Stakeholder Management” with Neeraj Shah.  

Popular topics of general interest ensured overflow crowds for the four educational seminars.

In the Vendor Showcase area, product demos were held by ClorDiSys Solutions, Cambridge IT Compliance, E&S Technologies, High Purity New England and Lives International. And, as a special bonus, Nidhi Maniar, R&D Associate at UMass Medical and winner of the Student Poster Competition, was on hand to present her poster and answer questions about her research.

The Annual Career Fair, a “show within a show,” provided a venue for leading area firms to meet potential new hires. For the first time, free tables were given to operating manufacturing companies to help them find qualified employees from among the ranks of our membership. In another first this year, we partnered with Career Builder to help source that talent and the feedback was positive all around.  We will be expanding that program next year, so if you are an operating company, be sure to sign up early.

Of course it wouldn’t be a Boston Area Chapter Product Show without our fun networking activities.  With the help of the Patriots Cheerleaders for Charity we raised almost $1000 for the Patriots Charitable Foundation.  With the backdrop of carnival games and food, we had live music provided by two great local bands, Stoli and Wolfpack.  And when the exhibitor floor closed at 7:30pm, nearly 800 joined us at nearby Bar Louis to relax and unwind with drinks, appetizers and a chance to meet Pats Defensive End Chandler Jones. 

The after party drew hundreds to Bar Louis, including Product Show Committee Co-Chair Steven Kennedy, shown here with Pats Defensive End Chandler Jones.

The Boston Area Chapter is pleased that this event continues to be offered free of charge, supported in full by our generous exhibitors. This includes free parking, free admission, free food and soft drinks and free educational seminars.  The Product Show is our Chapter’s flagship event and the revenue generated funds the Chapter and allows us to do many worthwhile things for our Members.  So on behalf of the Chapter, thank you to all our exhibitors for your continued support.  We look forward to your participation in 2015 and you are encouraged to pre-register and send in your deposit as soon as possible. Doing so will allow you to pick your spot in the exhibit area as soon as registration opens.

A Product Show like this does not happen without a lot of help from many people.  Volunteers are the backbone of this organization.  The Product Show Committee has already started work on next year’s Show.  If you would like to join the committee and help plan for 2015, please contact the Chapter office at  office@ispeboston.org   or 781.647.4773.  We are always looking for new volunteers to help make the Product Show bigger and better.

If you weren’t able to attend this year, you missed the event of the season. To those that did attend, thank you and we look forward to seeing all of you on October 7, 2015 at Gillette Stadium for the 24th edition of the Boston Area Chapter Product Show!


Educational Program Season Kicks Off with “Good Engineering Practices

by Robert Mitchell, Robert Mitchell Engineering, with photos by Joyce Chiu, Honeywell Safety Products  

The stunning atrium at Genzyme Center
in Kendall Square greeted attendees at
September's educational program.

The ISPE Boston Area Chapter 2015 educational program season kicked off on September 18, 2014 with a panel lecture in the Dr. Roscoe Brady auditorium at Genzyme Center in Cambridge. The topic for this event was “ISPE Good Engineering Practice, aka How to Make Friends with your Validation Group.” The panel was comprised of industry experts who must each operate within the precepts of Good Engineering Practice (GEP) on a daily basis.

The evening began with a presentation by Howard Sneider, a Senior Process Engineer at Clark, Richardson & Biskup (CRB) Consulting Engineers. Mr. Sneider discussed the typical engineering requirements that all engineers must abide by in order to satisfy the needs of the client. His presentation followed the natural progression from user requirements to risk assessment through design deliverables. Mr. Sneider demonstrated that the relatively recent guidance from ISPE and standard from ASTM closely align with the historical design sequence that he presented in the first part of his presentation. Mr. Sneider concluded with a few examples of how additional reviews and non-GMP regulated management systems can benefit the efficiency and thoroughness of the design.

The next presentation was by Jeanine Gigante, the Associate Director of Global Engineering and Technology for Genzyme. Ms. Gigante identified situations where the regulated oversight of engineering design has occurred too early in the design. Her response to ensure that oversight occurs at the appropriate time is an Engineering Quality Program developed within the Genzyme Global Engineering Group and endorsed by the engineering groups throughout the organization. The Engineering Quality Program can ensure GEP deliverables by defining roles and responsibilities, engineering processes, document management, change management and continuous improvement processes. Ms. Gigante shared her vision that a well implemented engineering Quality Program can result in an engineering deliverable with less inherent risk.

The last presentation was given by Paul Meehan, a Validation Manager at Shire. Mr. Meehan identified that the current requirements for validation have refocused the effort from a department of individuals back-checking the proposed design to anyone who obtains or generates documented evidence to verify that a system performs as specified. Mr. Meehan characterized the need for validation as the best answer to a query by a regulatory audit. In conclusion he identified that validation may not provide lower cost but may provide a higher return on investment, may not provide the most rapid start up but may minimize manufacturing downtime and may not improve the quality of an engineering design but may positively influence the culture that is responsible for that design. 

The evening concluded with about a half hour of questions from the audience from both the attendees at Genzyme Center and those participating remotely at the simulcast in Warwick, Rhode Island coordinated by the Chapter’s Geographic Outreach Committee. Questions included best practices for URS’s, methodologies for identifying like-for-like equipment changes, stakeholder management when reviewing documents, scheduling of validation/verification activities, and implementation of E2500.

On behalf of the Boston Area Chapter, the Program Managers would like to thank Genzyme for hosting this event. We would also like to thank each of the presenters for their insight, knowledge and expertise. And lastly we would like to thank the evening’s sponsor, Tufts Gordon Institute, whose support enables the Boston Area Chapter to provide high-quality educational programs such as this.








Page last updated: 5 November 2014