His background also includes extensive involvement in both internal and vendor audits, contributing to a strong understanding of compliance, data integrity, and system life cycle management. As Senior Executive Consultant at QFINITY, he helps life sciences companies and technology providers find innovative answers to the quality and validation challenges across all GxP areas created by operating in a highly regulated industry.
An ISPE member since 2001, Frank was on the guidance document teams for both editions of the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data and contributed to ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) as a chapter lead. He is an ISPE-Certified GAMP® trainer and the current Chair of the GAMP Global Steering Committee.
How Did Your Career Journey Unfold?
I have always been interested in science and have always aspired to work in research. I didn’t go to college right away. After graduating from school at the tender age of 17, I began vocational training and became a certified biology lab technician in the pharmaceutical industry. Then I went to university while still working in the lab and earned my degree in computer science and economics. My first job after that was writing SQL scripts for a pharma-covigilance database at Schering AG. It was fun. I loved it. And then I got sucked into computerized system validation when we implemented a new pharmacovigilance database. I loved that even more!
What Do You Enjoy Most About Your Work?
I enjoy using my creativity, experience, and knowledge to come up with the best and most efficient validation approach for the business process, the people, and the functions that are involved. Once you show teams that what we’re doing is not only required for regulatory compliance but also closely tied to ensuring quality and genuinely contributing to patient safety, they become quite open to the process, and it is really fun to work with them. Plus, it is great to hear from them after an audit or inspection saying, “Oh yeah, our documentation really did hold up well.”
What Do You See Next for the Industry?
AI is going to be the game-changer. I think that is a quantum leap, just like the invention of the first iPhone or the internet. AI will impact our work in two ways: First, by changing the systems we validate, because they will increasingly include AI components; and second, by enabling us to leverage AI ourselves to streamline the validation process and make it more efficient. I think we are on the brink of a truly new era, where this will have a significant impact on nearly everything we do.
And the other one is obviously that the regulations are evolving constantly. We are seeing a lot of activity in the EU lately, and the US FDA is constantly working on new regulations and guidance, addressing emerging areas such as machine learning and artificial intelligence. I think we will see massive changes to the regulations to address advancements in technology and to ensure compliance and maintain quality of our computerized systems.
What Benefit Do You Get from Being an ISPE Member?
After 25 years of being a member, I have an amazing group of people that I can reach out to with any question, no matter how stupid it may be. You get lots of good information and feedback from people who are not in your bubble. When you are working in a company, you can end up always within that corporate bubble, talking to other people who have been working in that same bubble for many years.
But when you reach out to other ISPE members, you have a platform for exchange. You get input from software providers or from other pharmaceutical companies, like “Oh, we have addressed this particular problem in such and such a way.” This is typically information that you could not easily obtain. For me, ISPE is a community that allows me to build a network I trust and a platform for exchange across the boundaries of individual organizations, truly bringing the industry forward.
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