In this episode, we’re joined by Paul Daniel, Senior GxP Regulatory Expert of Vaisala, who brings nearly 30 years of experience in pharmaceutical validation and temperature mapping. Paul shares the evolution of mapping from a technical task to a regulatory imperative, unpacking the misconceptions, equipment considerations and quality frameworks essential for accurate, compliant execution.



Key Takeaways:

(04:19) Modern data loggers reduce manual steps and lower mapping error rates.

(07:00) New mapping guidance added complexity and confusion to established practices.

(10:22) Mapping provides documented evidence your CTU operates in a controlled state.

(12:33) Misunderstanding mapping as simple logging indicates the lack of a validation framework.

(15:05) Superior equipment improves data quality and helps navigate inevitable deviations.

(23:26) If you don’t understand the tools, it’s time to outsource.

(26:28) Warehouse automation can streamline mapping with robotic logger placement.

(33:50) Deviations expose real-world system behavior and improve validation expertise.

Resources Mentioned:

Paul Daniel

https://www.linkedin.com/in/paul-daniel-37176518/

Vaisala | LinkedIn

https://www.linkedin.com/company/vaisala

Vaisala | Website

https://www.vaisala.com/en

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

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

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