Beyond the Checklist
Beyond the Checklist
Podcast Description
“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.
Podcast Insights
Content Themes
The podcast focuses on topics like regulatory requirements, culture in manufacturing, leadership, and innovation, with episodes exploring key areas such as automation's impact on quality, the role of AI in drug manufacturing, and the importance of data governance. For instance, the inaugural episode discusses pharma tech evolution with expert Mike Rutherford, highlighting his insights on the balance between regulatory expectations and practical risk.
“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.
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:
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
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