Beyond the Checklist

Performance Validation
Beyond the Checklist

“Beyond the Checklist” is a podcast that explores not only the essential aspects of cGMP but also explores the human factors that drive excellence in life sciences manufacturing. Through expert interviews, industry insights and real-world discussions, we uncover how culture, leadership and innovation shape a safer, more efficient path to market. 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.

Episodes

  1. What Pharma 4.0 Actually Looks Like on the Manufacturing Floor with John Coffman

    MAY 9

    What Pharma 4.0 Actually Looks Like on the Manufacturing Floor with John Coffman

    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. Key Takeaways: (04:32) A desire to make a real-world impact inspired a career in pharmaceutical manufacturing. (09:12) Cost pressures are driving more focus on efficiency and technology adoption. (13:11) Real-time batch release and predictive analytics are promising future AI use cases. (16:19) Regulatory compliance demands a rigorous investigation for any batch not made according to protocol. (19:30) Thorough investigations and strong CAPAs are top regulatory expectations for deviations. (22:09) Validation is shifting from traditional CSV to risk-based computer software assurance. (29:03) Purpose-built AI tools with guardrails improve reliability and reduce operational risks. (32:03) Early adopters of digital transformation will set new standards in manufacturing efficiency. (35:12) Continuous manufacturing and AI will define the industry’s future direction and competitiveness. Resources Mentioned: John Coffman https://www.linkedin.com/in/john-coffman-qwynai/ Qwyn AI | LinkedIn https://www.linkedin.com/company/qwyn-ai/ Qwyn AI | Website https://qwynai.com/ International Society for Pharmaceutical Engineering (ISPE) https://ispe.org/ Thank you for listening to “Beyond the Checklist.” Be sure to leave us a review and subscribe so you don’t miss any episodes.  For more information, visit www.perfval.com. #cGMPCompliance #FDARegulations #QualityAssurance #CQV

    42 min
  2. The Evolution of Pharma Tech with Mike Rutherford

    APR 7

    The Evolution of Pharma Tech with Mike Rutherford

    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 integrity and quality systems at ISPE and GAMP. He discusses the accelerating role of AI in pharmaceutical manufacturing, the critical importance of data governance and the human oversight still required to protect patient safety. Key Takeaways: (02:10) Building a career through industry engagement and volunteer leadership. (06:33) Why validation must balance regulatory expectations with practical risk. (11:19) Automation and data are redefining pharma manufacturing quality. (16:09) Why data quality is essential before applying AI. (18:23) Patient safety depends on human oversight and decision-making. (22:43) Sanity checks and technical depth are essential requirements in a digital world. (30:45) Career depth leads to stronger technical leadership and mentoring. Resources Mentioned: Robert Perks https://www.linkedin.com/in/robert-perks/ Donna Griffith https://www.linkedin.com/in/donna-griffith-a6556441/ Mike Rutherford https://www.linkedin.com/in/michael-rutherford-0451a99/ ISPE LinkedIn https://www.linkedin.com/company/ispe/ ISPE – International Society for Pharmaceutical Engineering Website https://ispe.org/ Eli Lilly LinkedIn https://www.linkedin.com/company/eli-lilly-and-company/ Eli Lilly Website https://www.lilly.com/ GAMP® 5 Guide – 2nd Edition Overview https://ispe.org/pharmaceutical-engineering/january-february-2023/what-you-need-know-about-gampr-5-guide-2nd-edition Thank you for listening to “Beyond the Checklist.” Be sure to leave us a review and subscribe so you don’t miss out on any episodes.  For more information, visit www.perfval.com.  #cGMPCompliance #FDARegulations #QualityAssurance #CQV

    36 min

About

“Beyond the Checklist” is a podcast that explores not only the essential aspects of cGMP but also explores the human factors that drive excellence in life sciences manufacturing. Through expert interviews, industry insights and real-world discussions, we uncover how culture, leadership and innovation shape a safer, more efficient path to market. 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.

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