[Workshop] Performance Qualification Workshop with Modality Solutions

Workshop: How to Implement Your PQ Strategy

Join our in-person workshop in Houston, TX immediately following the ISTA Annual Forum.

📅 Thursday, May 4, 2023

🕕 9:00 AM - 12:00 PM CT

📍Marriott Marquis Houston, Floor 3 (same location as the ISTA Forum)

Coming to Houston for ISTA or just in the area? Join Modality Solutions to learn more about planning and implementing a cold chain strategy that supports your overall approval strategy. We'll show you a sneak peek of our Transport Sim Lab, host a workshop on Performance Qualifications, and share insider tips for your cold chain.

9:00-9:15: Introduction to Cold Chain Engineering + Modality Solutions

What can a cold chain engineer do for your cold chain approval strategy?

9:15-10:15: Performance Qualification Workshop (PQs)

How to perform a Performance Qualification - going beyond best practices
Taking the ISTA Recommendations for PCG-03 and how to actually implement them in your process

10:15-10:45: Applying Heat Transfer to PQ Root Cause Failure Analysis

The basics of heat transfer
Common root-cause failures

10:45-12:00: Root Cause Failure Analysis of PQ Case Study

Look at the data from a real-life PQ example and learn how to address out-of-temperature PQs from Modality Solutions' experts

Modality Solutions has been a leader in biopharmaceutical cold chain engineering for over a decade, with a team of experts in regulatory affairs and life sciences. Our deep expertise in packaging design, shipping lane validation, drug product transport simulation testing, and stability studies allows us to provide clients with a comprehensive regulatory approach, ensuring compliance with the latest global regulations. With a focus on global regulatory requirements, our team helps clients navigate complex regulations, seeking out commonalities and optimizing the validation process. We are dedicated to delivering the last mile of the supply chain, providing the continuity and control necessary to ensure successful product delivery to the patient.