Episode Summary: In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down with Sean Merrill, a Validation Engineer at Testo with over 11 years of experience in commissioning, qualification, and validation. They explore the critical history of the regulatory landscape and how modern risk-based approaches are streamlining safety protocols in the pharmaceutical and industrial sectors.

The conversation traces the reason behind modern regulations to contextualize the current integrated approach that prioritizes innovation and efficiency. Sean explains how companies can leverage documentation and third-party expertise to turn validation from a necessary evil into a value-added asset for patient safety and product quality.

About the Guest: Sean Merrill is a Validation Engineer at Testo. With more than a decade of experience in commissioning, qualification, and validation, he specializes in helping organizations navigate complex regulatory environments and operational nuances. Sean is an expert in implementing risk-based strategies for pharmaceutical manufacturing, logistics, and distribution centers, ensuring that facilities and equipment consistently meet the highest standards for their intended use.

Key Points:

• Defining CQV: A breakdown of Commissioning, Qualification, and Validation, and how these distinct processes work together to ensure a facility is suitable for its intended use.
• The Catalyst for Regulation: How historical tragedies—including the 1950s Cutter incident involving the polio vaccine and the thalidomide morning sickness remedy—led to the first FDA GMP regulations in the 1960s.
• From Overkill to Risk-Based Logic: The evolution from the 1980s "validate everything that moves" mindset to modern, integrated methods that prioritize innovation and value.
• Leveraging Documentation: How integrating commissioning and qualification allows organizations to use well-documented supplier testing to satisfy regulatory requirements without redundant effort.
• Industry Standards: An overview of essential guidance used in the field, including ISPE’s Baseline Guide 5 and ASTM E 2500.
• Testo’s Consultative Approach: How Testo serves as an objective third party, offering a buffet of services from drafting validation master plans to conducting specialized temperature mapping.

Resources:

• https://www.testo.com/en-US/solutions/pharmaceutical-validation-qualification
• https://www.testo.com/en-US/services/validation-and-mapping-services
• https://www.testo.com/en-US/solutions/pharma-solutions

Episode Summary:

In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down again with Jim Bacon, whose decades of pharmaceutical logistics experience spans domestic and international cold chain operations. In this episode, Bill and Jim take a deep dive into ensuring the integrity of the pharmaceutical cold chain. Jim shares how the industry’s most successful logistics programs are built not on transactions, but on strategic partnerships that are rooted in trust, communication, and shared responsibility.

Jim introduces the critical "core team" concept, which emerged early in his career. This approach emphasizes a strong internal team that collaborates with a robust network of external partner suppliers to navigate the complexity of cold chain processes successfully. He explains why treating suppliers as vendors undermines accountability and why true partners must be integrated into your processes.

The conversation explores supplier qualification, regulatory expectations, mock shipment trials, AI, and the lessons learned from the COVID-19 vaccine rollout. Through it all, Jim returns to one central principle: ownership is everyone’s job, and when partners understand their role in protecting critical therapies, patients ultimately benefit.

About the Guest:

Jim Bacon is a cold chain logistics expert with decades of experience across manufacturing, operations, sales, and technical consulting in the pharmaceutical and biotech industries. His work has focused on advancing best practices, implementing robust monitoring systems, and improving industry-wide cold chain acumen. He is the President and Founder of Stay Cool Logistical Consulting, LLC.

Resources

Testo Saveris Pharma Solutions

Testo North America Blog: Data Storage Ownership: Who Owns Data and Manages Support in Pharma Monitoring?

Episode Summary:
In this episode of Measuring Up: Thinking Out Loud, host Bill White speaks with Patrick Girten, a pharmaceutical logistics expert whose career journey spans aviation, firefighting, and pharmaceutical operations. Patrick shares how the discipline and accountability from his early experiences translate into protecting life-saving therapies during transport.

From the evolving complexities of cold chain management to the human element that drives vendor compliance, Patrick highlights why logistics is never just about moving packages; it’s about safeguarding patients. He recalls a powerful Christmas Eve shipment that reached a young cancer patient in Canada, a moment that reshaped his entire perspective on logistics and leadership.

The conversation explores regulation, vendor relationships, technology, and the balance between metrics and mission with one central theme: remembering the patient in every package.

About the Guest:
Patrick Girten is a pharmaceutical logistics expert with nearly two decades of experience ensuring therapies reach patients safely and on time. He began his career in aviation and firefighting before transitioning into the pharmaceutical industry, where he worked across various areas, including manufacturing, quality compliance, distribution, and logistics. Patrick is known for connecting the technical side of cold chain operations with the human responsibility behind every shipment.

Next Steps:

Trusted Pharmaceuticals Require Trusted Logistics
Discover how Testo’s monitoring and compliance solutions help ensure that every shipment maintains product integrity so you can help protect patients from production through delivery.

Resources

Testo Saveris Pharma Solutions