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Podcast

“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.

Modernizing Validation Without Compromising Compliance with Charlie Wakeham

Charlie wakeham

Director at WakeUp to Quality

Host Robert Perks speaks with Charlie Wakeham, Director at WakeUp to Quality and Chair of the ISPE GAMP Global Steering Committee. Charlie gives us the origin story of GAMP, including the tragic failures that underscored its necessity, and offers insight into how GAMP 5 Second Edition is helping teams move from documentation-heavy routines to risk-based, value-driven validation. She explains how GAMP supports innovation when applied with critical thinking and expertise, from AI to cloud platforms.

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

Robert Perks

Digitalization LinkedIn

Bio

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).

Brad Henry

Vice President of Services Products LinkedIn

Bio

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.