Richard Tharin, MS, RAC, has more than 20 years in Biotech, Medical Device and Pharma regulatory affairs and as much time as a Cell Biologist, Biochemist and Molecular Biologist. He is the founder and CEO of Cerneos Group, LLC, an end-to-end life science consulting firm. He has managed programs in vaccine, cell biology and diagnostic product development from early stage to commercialization.
Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products.
Objectives of this three day course are to provide an understanding of Medical Device process validation, explaining how, when, where and why to validate processes.
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