In this webinar we briefly outline the practices, processes and regulations governing calibration in GxP-regulated applications. We also analyze several calibration-related Form 483s and Warning Letters issued over the last few years in a range of regulated industries (Drugs, Medical Devices, Nutraceuticals, and Cosmetics). Each Form 483 and Warning Letter is a cautionary tale for those calibrating instruments and devices for use in federally regulated applications.
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Vaisala’s Senior Regulatory Expert Paul Daniel is joined by Heather Wade of Heather Wade Group, LLC. Paul and Heather will review several Warning Letters and 483 observations in order to understand the technical aspects of each calibration failure and discuss the principles and practices that can solve the violations. To err is human; failure to calibrate properly can result in enforcement actions. This webinar provides practical lessons on how to meet FDA calibration requirements and avoid dealing with such actions.
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.
Heather Wade is an ASQ-CCT and ASQ-CQA metrologist. Before moving to her career in calibration, Heather’s experience included work as a microbiologist, filter test specialist, laboratory compliance officer, and extraction and analytical chemist. She is also a co-author of The Metrology Handbook, 2nd Edition.