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.
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
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