This year's 23rd Annual Validation Week, held on October 17-19, 2017 in Philadelphia, PA celebrated our award winners in a ceremony acknowledging the best and brightest in the validation industry. For a complete list of winners, please click here.
Below is the acceptance speech for Cliff Campbell, who won this years' Kenneth G. Chapman Award. With this speech, he highlights his relationship with the compliance pioneer, who in 1998 won IVT's Lifetime Achievement Award.
I was totally surprised when Paul [Paul Pluta, Ph.D. Editor-in-Chief of IVT journals] contacted me last week to tell me I was to receive this year’s Ken Chapman Award from IVT. I knew Ken very well, having first met him when he’d retired from Pfizer and set up his consulting company Drumbeat Dimensions. I visited him at his home in Groton a number of times, and got to see his legendary swimming pool, so the relationship was a personal as well as professional one.
Ken was a great believer in deep simplicity, and it never ceases to amaze me that his process criticality triangle, which speaks to set-points, risk, protection and remediation in such an elegant manner, is so aligned with the 3-Stage PV Lifecycle that is now in play. Thinking about it a bit further however, it’s no surprise at all, given that Ken was such a compliance pioneer, who greatly influenced the authors and the contents of our current guidances.
For those of you that do not know me, let me say that I have tried to take a leaf from Ken’s book, urging industry to take a more methodical and self-assured view of validation, and dare I say it, to have some enjoyment along the way! For those of you that do know me, and who have collaborated with me on projects and strategies, I want to say thank you for your continued commitment and support. There isn’t a day goes by when I don’t gain new insights from the relationships and interactions with my clients.
I have also been fortunate to have had access to FDA and HPRA management and policy advisors in the course of my career. This has been of immense value and a real privilege, and has resulted in a number of co-authored publications on validation and criticality etc., including JVT. I’d like to specifically mention and thank FDA’s Rick Friedman and Paula Katz, and Kevin O’Donnell and Deirdre O’Keeffe at HPRA.
Whenever I think of Ken Chapman, I also remember the late Joe Phillips, an FDA stalwart of long standing and a contemporary of Ken’s. Though working on the other side of the fence, Joe’s advice hit the nail on the head and was highly in sync with Ken’s worldview. “Just give me good science” is a reasonable and fundamental regulatory request, and another forerunner of 3-Stage PV.
Finally, and most importantly, I want to thank my wife Frances and daughters Elizabeth & Sarah for their loyalty and encouragement. By its nature, consultancy carries its own risks, and involves a high degree of time on the road and away from home. It’s been in the greatest of causes however, and tremendously satisfying, and we work as a team.
Cliff Campbell B.E, Oct 2017