Summary

In this episode of Measuring Up, Thinking Out Loud, host Bill White sits down with Karen Greene, Vice President of Client Solutions at Network Partners Group and Principal Consultant at Canyon Labs, to discuss the critical intersection of packaging engineering and temperature control. With over 40 years of experience in the life sciences industry, Karen explores the complexities of cold chain applications and the necessity of protecting temperature-sensitive products as they move from point A to point B.

The conversation delves into the vital work of the International Safe Transit Association (ISTA), where Karen serves on the Board of Directors. She explains how ISTA sets the standards for distribution packaging and how its Pharmaceutical Committee provides the industry with the thought leadership and test profiles needed to safely ship sensitive medical devices and biotech products.

About the Guest

Karen Greene is Partner and VP, Client Solutions – Packaging Engineering at Network Partners Group and Principal Consultant at Canyon Labs. She is a seasoned life sciences packaging engineering professional with more than 40 years of industry experience. Karen is an IoPP Certified Packaging Professional (lifetime CPP), a global board member of ISTA, the International Transit Association, and a board member of the ISTA Pharma committee. Additionally, she is a member of ASTM F02 Flexible Barrier Packaging Committee and an ISTA 7E-certified auditor.

Karen’s expertise spans packaging testing, compliance, quality systems, design, and validation across medical device and pharmaceutical product portfolios. In her dual roles at Network Partners Group and Canyon Labs, she leverages this deep technical and regulatory background to help clients bring safe, effective, and compliant products to patients.

She holds a bachelor’s degree from Holy Cross College in Worcester, MA, and a certificate in engineering management from the University of California, San Diego.

Resources

Guest Contact:

LinkedIn: https://www.linkedin.com/in/karen-greene-a391055/

Measurement Solutions:

Testo Environmental Monitoring Systems

Summary

In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down again with Jim Bacon, founder of Stay Cool Logistics, to break down the complexities of risk management in pharmaceutical logistics.

Jim comes back to his "Four Quadrants of Risk" (financial, hazard, strategic, and operational) concept to explain how understanding these categories allows organizations to better protect product integrity and patient safety. The conversation explores the critical shift from a silo mentality to a total cost calculation, where procurement, quality, and finance work together to decrease risk tolerance.

Jim also shares a real-world example of how a robust cold chain process can lead to innovative self-insurance strategies, such as stock-throughput coverage. Finally, the duo discusses the evolving role of technology, emphasizing that human instinct remains the bedrock of successful risk mitigation.

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.

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