Two industry experts bring combined experience of over four decades in qualification, mapping, and monitoring to discuss best practices for controlled-temperature chambers in GxP applications. We welcome your questions in advance and will leave time during the webinar for Q&A.
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Regulatory requirements change slowly, but industry practice is increasingly affected by two key factors: technological advances and quality requirements. The intersection between long-standing regulations and new technology is often found in best practice guides published by accrediting bodies or professional associations like the International Society of Pharmaceutical Engineers (ISPE).
These organizations are able to leverage their members’ subject matter expertise in GxP compliance efficiently and then disseminate that information broadly. The basic goal of good practice guides is sharing knowledge to support a competitive and compliant life science industry. The highest goal is ensuring the safety, quality, and efficacy of products.
One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Deviations in temperature can have dramatic consequences on product quality, making management of controlled-temperature chambers (CTCs) a critical practice from R&D to distribution.
In this webinar, Vaisala's Paul Daniel is joined by Genesis AEC's Validation Director Nathan Roman to discuss their industry experience with controlled-temperature chambers and their personal contributions to the recent revision of the ISPE's "Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring". Join the discussion to learn how industry is solving old challenges in new ways.
If you cannot attend the live session, we will send all registrants the recording.
Learn more about Genesis AEC.
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 is a graduate of University of California, Berkeley, with a bachelor's degree in biology.
Nathan Roman is a project executive with extensive experience in providing quality assurance to many types of organizations. Versatile experience in the pharmaceutical and biotechnology research and manufacturing industry implementing Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Nathan is a proven leader and helps people get everything they want out of their business and excels at assessing situations and developing creative solutions.
Through his leadership he has built healthy teams that operate with real accountability and promotes healthy, functional and cohesive teamwork. He is passionate about helping others develop robust processes and implement changes that improve efficiency and reduce risk. Nathan has an entrepreneurial spirit, operates with high integrity, and inspires others to be honest and productive team members.