Beyond the Checklist

Host Brad Henry is joined by Sean Merrill , Director of Quality at Langham Logistics , to explore the often-overlooked role logistics plays in safeguarding patient safety in the pharmaceutical supply chain. Sean shares how his background in validation shaped his approach to quality in the 3PL space, the regulatory complexities these providers face, and why warehousing and transportation remain two...

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...

In this episode, we’re joined by Paul Daniel , Senior GxP Regulatory Expert of Vaisala , who brings nearly 30 years of experience in pharmaceutical validation and temperature mapping. Paul shares the evolution of mapping from a technical task to a regulatory imperative, unpacking the misconceptions, equipment considerations and quality frameworks essential for accurate, compliant execution.  Key...

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...

Welcome to the inaugural episode of “Beyond the Checklist”! Hosts Robert Perks and Donna Griffith are joined by Mike Rutherford , Principal/CEO of Rutherford Consulting, LLC, former interim CEO of ISPE and longtime pharma quality leader. With 37 years in the industry, Mike shares his journey from early lab robotics at Eli Lilly to shaping global best practices in computer systems validation, data...