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Data Integrity Educational Program Reaches Members at Four Locations

by Brijesh Patel and Jimmy Hughes, Shire

The June educational program was held at the Crowne Plaza in Warwick, RI with live simulcasts in Worcester, MA at WPI, Medford at Tufts Gordon Institute and Portsmouth, NH at Redhook Ale Brewery. This was another first for the Chapter - a single educational program simultaneously presented at four locations in three New England states. Congratulations to the Educational Program and the GO (Geographic Outreach) Committees for working together to make it happen. The program focused on Data Integrity and the draft guidance recently published by the FDA and was a great success with over 75 attendees whose enthusiasm demonstrated broad interest in the topic.

Attendees in at all four locations shared food, drink and conversation prior to the presentations.

The event was kicked off with a great food, cold beer and a networking reception at the Crowne Plaza in Warwick where the live presentations took place. Similar gatherings were held at the simulcast locations in Worcester, Medford and Portsmouth. Meeting Manager and Chapter Vice President Jack Campion welcomed the crowd and introduced our speakers, Robert (Bob) Wherry of Paraxel International; and Heather Longden of Waters Corporation. Bob and Heather both gave excellent presentations covering several aspects of the topic including FDA's current focus, future trends and best practices, audit preparation and working with your software vendor.

Speakers Heather Longden and Bob Wherry

Bob works for Paraxel International as a Principal Consultant in the Strategic Compliance and Risk Management group with a focus on Data Integrity and Inspection Readiness. He gave audience members a glimpse into the draft guidance on data integrity recently published by the FDA and discussed data integrity challenges, best practices, the FDA's current focus and future trends in the field. 

Heather Longden, Senior Marketing Manager from Waters Corporation, interacts with regulatory bodies, industry groups and sales representatives across the globe. She talked about how to work with software vendors and what questions to pose before an audit. She also touched on computer systems validation, and some of the technical aspects of vendor testing and how to leverage it the right way. Heather concluded by addressing technical and procedural control and how to successfully manage a regulatory inspection.

Meeting Managers Brijesh Patel (l) and Jimmy Hughes (r)

Not only did Bob and Heather provide information that was simulcast to sites in four different cities, they were also able to receive questions from attendees no matter where they were located and provide answers in real-time. Thanks to our presenters, the EPC and GO Committees, and our simulcast site coordinators, Jared Marshall (Tufts), Jennalynn Coulp-Yu (Portsmouth), and Dan Mardirosian, Kristin Marengo and Kristen Benoit (WPI), all of whom worked together on another successful first for the Chapter. And, last but not least, thank you to event sponsor Commissioning Agents for their continuing support for the Chapter's educational programs.


Summer Golf Outing Travels to Lake Winnipesaukee

by Jim Grunwald, DPS Engineering, with photos by Tom Coyner, E-Volve Systems

This past August 8, the Chapter took a different approach to our Annual Summer Golf Outing by searching for a course outside of greater Boston with the goal of providing a really unique experience in a world class setting. Golf Committee members found Lake Winnipesaukee Golf Club in September 2015 and were impressed with the course and its staff. The committee decided the venue would be a great draw despite the travel commitment and their bet paid off. The event, venue, weather and turnout were crazy good and the ISPE contingent made the most of their time at this wonderful venue. The travel commitment was a small price to pay for such an exceptional day.

Congratulations to this year's winners:

  • Foursomes
    • First: Tim Crowley, Peter DeGennaro, Justin Tucker, Geoff Wilkinson
    • Second: Rod Cole, Kristin Dangelo, Eileen Heffernan, Shaun McCormack
    • Third: Newman Flanagan, Dan Ramsey, Paul Sullivan, David Surette

  • Longest Drive
    • Kathy Melia
    • Steve Robak

  • Straightest Drive
    • Eileen Heffernan
    • Rich Trabucco

  • Closest to the Pin
    • Dianne Barrette
    • Rob Melchionda

The Chapter would like to thank our many sponsors whose support made this event possible: AHA Engineers, A/Z Corporation, Albireo Energy, Boston Analytical, Commissioning Agents, Commodore Builders, DPR Construction, DPS Engineering, J. Calnan & Associates, JENSEN HUGHES, PIDC Construction, Paradigm Construction, R.W. Sullivan Engineering, Reflex Lighting, Sentrol, Structure Tone, Superior Controls, TRIA, UltraFiltronics, and ValSource.

The Chapter would also like to thank everyone who attended, with special thanks to those whose efforts helped make the event a success: the staff at Lake Winnipesaukee Golf Club; the Golf Committee of Paul Sullivan, Tim Crowley and Jim Grunwald; and Erin Young and the Chapter's admin staff at CAMI.

And not only was a fine time had by all but our sponsoring companies, participants and guests all contributed to the Boston Area Chapter as a portion of the proceeds from the event go to the Chapter's Joel Goldenberg Scholarship Program.

Page last updated: 14 September 2016