Host Brad Henry is joined by Sean Merrill, Director of Quality at Langham Logistics, to explore the often-overlooked role logistics plays in safeguarding patient safety in the pharmaceutical supply chain. Sean shares how his background in validation shaped his approach to quality in the 3PL space, the regulatory complexities these providers face, and why warehousing and transportation remain two of the highest-risk operations for product integrity. He discusses the importance of aligning quality expectations through clear project scope and communication, the adoption of AI-powered drones to enhance inventory verification and how quality is ultimately everyone’s responsibility, especially when lives are on the line.
Key Takeaways:
00:00 Introduction
05:45 Navigating 50 sets of state regulations for 3PLs adds complexity beyond manufacturing.
07:09 Why alignment on regulatory expectations is critical to avoid audit challenges.
08:33 A well-defined scope and regular check-ins are non-negotiables for project success.
09:45 Best practices for temperature-controlled storage and risk mitigation.
10:33 Why 3PLs and transportation remain the highest risk for product stability.
12:09 How Langham safeguards data integrity with redundancy and cybersecurity.
15:57 AI-powered drones are transforming inventory management and accuracy.
17:54 Patient safety must remain the focus for any organization handling critical therapies.
20:03 Quality is everyone’s business, from the warehouse floor to executive leadership.
Resources Mentioned:
https://www.linkedin.com/in/sean-merrill/
Langham Logistics | LinkedIn
https://www.linkedin.com/company/langham-logistics/rrill/
Langham Logistics | Website
https://www.elangham.com/
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For more information, visit www.perfval.com.
#cGMPCompliance #FDARegulations #QualityAssurance #CQV
Host Robert Perks speaks with Charlie Wakeham, Director at WakeUp to Quality and Chair of the ISPE GAMP Global Steering Committee. Charlie gives us the origin story of GAMP, including the tragic failures that underscored its necessity, and offers insight into how GAMP 5 Second Edition is helping teams move from documentation-heavy routines to risk-based, value-driven validation. She explains how GAMP supports innovation when applied with critical thinking and expertise, from AI to cloud platforms. This conversation is fascinating for professionals building a culture of intrinsic compliance and continuous improvement.
Key Takeaways:
(04:54) GAMP emerged from real-world failures and the urgent need for safer computerized systems.
(06:07) Validation is now expected, but quality execution remains inconsistent across the industry.
(09:25) GAMP 5 Second Edition promotes a risk-based, critical-thinking approach to validation.
(12:36) Intrinsic compliance is achieved through leadership, governance, and strong data integrity practices.
(14:42) Validation should be a strategic tool to ensure return on investment and patient safety.
(18:02) Adoption of AI and ML requires caution, transparency, and human oversight to ensure safe outcomes.
(22:54) Commissioning and qualification should align with validation as part of one continuous process.
(25:37) Empowering future professionals means moving beyond checklists and fostering independent, critical thinking.
Resources Mentioned:
https://www.linkedin.com/in/charliewakeham/
WakeUp to Quality | LinkedIn
https://www.linkedin.com/company/wakeup-to-quality/
WakeUp to Quality | Website
https://wakeuptoquality.com/
International Society for Pharmaceutical Engineering (ISPE) Website
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
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:
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:
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:
https://www.linkedin.com/in/robert-perks/
https://www.linkedin.com/in/donna-griffith-a6556441/
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
