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