Details 
#605 Process Validation This workshop will cover the elements of process validation and present industry “best practices”. Topics covered in the workshop will include design verification and validation, process validation planning, and installation, operation and performance qualification, and process validation. Applicable FDA Quality System regulations will be reviewed for participants working in medical devices and in vitro diagnostics. The class format includes interactive group exercises designed to illustrate the various aspects of a validation program Course length: 8 hours Instructor Bio: Dr. Wayne Schrier has over 15 years experience developing and commercializing in vitro diagnostic tests and medical devices for start up and Fortune 500 corporations, including Beckman-Coulter, Primary Care Diagnostics (formerly SmithKline Diagnostics), where he was Director of Product Development. His consulting practice focuses on quality systems development, product development, and process validation.
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