In this session, Vaisala’s Paul Daniel, GxP regulatory expert, explores how adaptable environmental monitoring systems help small-scale, high-speed cell and gene therapy (CGT) and Advanced Therapy Medicinal Products (ATMP) facilities maintain compliance as they grow.
Cell and gene therapy and ATMP manufacturing moves fast—from personalized, small-batch production to rapid facility expansion. Maintaining GMP compliance in this environment requires monitoring systems that scale with your process. Manufacturers of cell and gene therapies and ATMPs face unique challenges: ensuring traceability, rapid turnaround, and zero tolerance for downtime while production models shift from scale-up to scale-out.
This webinar covers monitoring requirements specific to cell and gene therapy and ATMP operations, including multi-site data integrity, cryogenic storage, and rapid system validation. Learn how scalable monitoring solutions can reduce risk, speed implementation, and future-proof your operations against evolving regulatory and technological demands.
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Paul Daniel is the Senior GxP Regulatory Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.
At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.
Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.
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