Two industry experts bring combined experience of over four decades in validation, mapping, and monitoring to discuss best practices for controlled-temperature chambers in GxP applications.
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.
Paul and Nathan begin with a brief overview of Good Distribution Practice and changes to temperature mapping in the regulatory landscape over the years. Based on regulatory trends, they discuss how to choose sensors for mapping and monitoring applications, as well as calibration and qualification expectations from regulatory bodies, active vs. passive controlled temperature chambers, and good documentation practices.
Paul and Nathan both contributed to the latest update of the ISPE’s CTC Good Practice Guide and discuss the changes they were involved in.
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Paul Daniel 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.