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“Beyond the Checklist” Podcast
Join us as we navigate the complexities of regulatory requirements while highlighting the people and processes that elevate compliance from a box-checking exercise to a mindset of continuous improvement.
In the highly regulated world of pharmaceutical, medical device and biotechnology manufacturing, compliance is critical — but true quality goes beyond the checklist.
What Pharma 4.0 Actually Looks Like on the Manufacturing Floor
John Coffman
Co-Founder and CTo, Qwyn AI
On this episode, hosts Robert Perks and Brad Henry are joined by John Coffman, Co-Founder and CTO of Qwyn AI. John brings over two decades of experience in pharmaceutical manufacturing, having held leadership roles at Thermo Fisher Scientific, Elanco, and Eli Lilly. His career spans quality control, Lean Six Sigma, operations and site leadership — culminating in his current focus: applying AI to solve systemic challenges in deviation management. He shares practical insights on the evolving role of AI, the pressures driving digital transformation and what companies need to do to stay competitive.
About the Podcast
On Beyond the Checklist, you can expect informative conversations and news on the current state of compliance in pharmaceutical and biotechnology manufacturing, along with a forward-looking perspective on the future of the industry. Our experts will explore not only the essential aspects of cGMP but also the human factors that drive excellence in life sciences manufacturing. Through expert interviews, industry insights and real-world discussions, we aim to uncover how culture, leadership and innovation shape a safer, more efficient path to market.
Meet Our Hosts
Robert Perks
Digitalization LinkedInBio
Robert is a process and manufacturing automation and applications professional with over 20 years of experience in the pharmaceutical industry. He excels in challenging situations across diverse manufacturing environments and is known for building strong, multidisciplinary project teams. Robert’s teams have successfully implemented complex manufacturing solutions worldwide, developing cost-effective solutions that align with larger strategic models. He has contributed as the past Chair of the ISPE Annual Meeting Planning Committee, a steering committee member of the PAT/LCS Community of Practice, and a member of the Digital Transformation Special Interest Group at the Institute of Measurement & Control (UK).
Donna Griffith
Director of Technical Services LinkedInBio
With over 20 years in the pharmaceutical industry, I have dedicated my career to leading teams in Commissioning, Qualification, and Validation (CQV). My focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation. I believe in the power of quality at every step to achieve excellence, a principle that aligns perfectly with Performance Validation’s values.
I live in North Carolina with my two children on our 18 AC farm. I love being outdoors, tending to our animals and my large garden.
Donna joined Performance Validation in 2024 as the Director of Technical Services. Her experience will help bridge client needs with the right solutions, expanding Performance Validations’ reach and providing clients with unmatched support.
Brad Henry
Vice President of Services Products LinkedInBio
With over 23 years of experience in the industry and at PV, I have delivered projects over a wide range of technologies. Through hard work and developing my career path here at PV, I have been able to work my way up from Division Director to Vice President in 2010, to Vice President of Services Products in 2023. It is extremely rewarding to be able to support and mentor new team members as they begin to develop their own skillset and learn the validation and commissioning industry.
I currently live in Shelbyville with my wife, two daughters, our papillon Willow, our many cats, and even chickens from time to time. I enjoy being outdoors, camping, hiking, backpacking, and watching my girls’ sports teams. And as a native Wisconsinite, I am an avid Green Bay Packers and Milwaukee Brewers fan.
Brad joined Performance Validation in 1999 and has provided services to the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.
