Process Validation for Drugs and Biologics
Training Course - Los Angeles, CA, United States
Process validation is not a curse invented by regulators and pushed onto a company by QA staff. Instead, it is a legal requirement in the pharmaceutical industry. The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products.
(Courtesy of logo of CFPIE, via cfpie.com)
Mon, Jun 17, 2013 - Tue, Jun 18, 2013
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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