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/

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For more information, visit www.perfval.com.

#cGMPCompliance #FDARegulations #QualityAssurance #CQV