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:

Sean Merrill

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/

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

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:

Charlie Wakeham

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:

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