The Evolution of Pharma Tech with Mike Rutherford

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Beyond the Checklist

Performance Validation

5 episodes

3 days ago

“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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Science

Business,

Management

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The Evolution of Pharma Tech with Mike Rutherford

Beyond the Checklist

35 minutes 30 seconds

7 months ago

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