Product Show Educational Program Attracts Record Turnout

by Peter J.B. Teague

The 16th Annual Product Show held at Gillette Stadium on October 17th was indeed a record setting event for the Boston Area Chapter, with eight successful educational programs drawing over 530 attendees and "fans" of ISPE. Kick-off took place at 1pm with Keynote Speaker Deborah M. Shelton, Special Counsel with Sheppard, Mullin, Richter & Hampton LLP, who flew in from Washington, DC. Ms. Shelton concentrates her practice in FDA law, with a particular emphasis on regulatory issues relevant to the pharma, biotech, and medical device industries. Nearly 90 attendees listened attentively to her information-packed presentation, The Hot and Heavy Debate: Biosimilars in the US and the Potential Reshaping of the Biotechnology Landscape. Some key points that Deborah covered included the status of federal laws governing biogenerics, abbreviated approval pathways, and the FDA's current opinion on the subject.

The "first quarter" of the program included Greg Rutlic and Paige Kane, both of Wyeth Biotech, who presented Back to the Future: GEP, GAMP, & You, which covered such timely topics as Good Engineering Practice and what's new in the ISPE GAMP 5 guide, as well as some great examples.

George Dainis (Industrial Facilities Design, Inc.) spoke on Capturing the Need: Preparing a User Requirement Specification (URS). Nearly 50 persons attended George's talk, which included something for everyone, as he explained how a thorough URS document is extremely important to the success of a project for both the vendor and the end user. He also gave examples of detailed requirements for a URS, covering items to include and - just as important - those to avoid.

Jack Greene (Alkermes) presented Using ISA-88 and GAMP to Reduce Plant Startup Timelines. This was a great talk on S-88, as Jack included everything from definitions and traditional C&Q (Commissioning & Qualification) approaches for beginners, to advanced ASTM E-55 C&Q hybrid models and lessons learned from his years of experience with the subject.

Next, three experts teamed-up for a state-of-the-art presentation on monitoring water systems for the presence of rouge and creating a novel predictive maintenance program. Peter Petrillo (Millennium Facilities Resources, Inc.), James Dean Vogel, P.E. (Process Facilities Services, Inc.) and Jeffrey Pouliot (Amgen) presented an extremely interesting talk, while a record 100 attendees followed closely along. Is Rouge Really a Problem? A Science-Based Approach to Clean Steam and WFI System Maintenance started with background information on rouge and passivation. This introduction, combined with analytical test methods, and a great case study with new data, proved to be a "big hit" with the audience.

A 5pm "halftime" keynote speaker was planned this year and was successful in helping to draw additional attendees during the second half of the show. David Petko (Auxilium Pharmaceuticals, Inc.) was actually brought back by popular demand, as a result of attendee feedback from online ISPE surveys. David's presentation on The End of Validation as We Know It: A Science and Risk Based Approach to Commissioning and Qualification at the joint ISPE Boston Area/New England Chapter session in June was so successful that he gladly returned for an encore presentation. The ASTM E55.03 working group (which David co-chairs) was responsible for releasing the new ASTM E2500 standard on specifying, designing and verifying pharmaceutical manufacturing systems and equipment. David's talk included up-to-date information on the new standard and he was later joined by speaker Graham Wrigley, PhD, who walked through a case study on the subject from Pfizer, where he is a Senior Manager.

Chuck Crumpton (Medpoint, LLC) flew in from Greenville, SC for a super "fourth quarter wrap-up," ending a great day (and night!) of presentations by teaching attendees to Make Your Career Rock! It was certainly a great title for a great talk. Although it was scheduled later into the evening and thus fewer persons were in attendance, the audience didn't want to leave when the presentation concluded! Chuck stayed well past his scheduled time just to answer questions and to meet one-on-one with many persons seeking to advance their careers. Rumor had it that he was giving autographs too!

Overall, the sessions were very educational and certainly timely for the industry. The speakers were presented with ISPEpersonalized gifts and received great ratings in the "fifth quarter report" (i.e. the after-show survey) as well. Several of them commented that this was the most fun show they have presented at and the audiences were great! This win was only possible, however, through a team effort from ISPE Education Program Committee (EPC) members, who worked extremely hard to make our "game day" a success! Many thanks to our entire team!

If you would like to join the EPC and help out with our upcoming monthly programs, as well as Product Show 2008, please contact Chapter Manager, Amy Poole at 781-647-ISPE or ispe@camihq.com. I hope to see you soon at one of our upcoming ISPE Boston Area Chapter Educational Programs and also next year at an even BIGGER and better Product Show 2008!