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ME 540 Validation in Life Sciences Manufacturing

Validation of a pharmaceutical manufacturing process is an essential requirement with respect to compliance with Good Manufacturing Practices (GMP). Course covers: validation concepts for process, equipment, facility, cleaning, sterilization, filtration, analytical methods and computer systems; validation Master Plans, IQ, OQ, and PPQ protocols; and validation for medical devices.

Credits

3

Cross Listed Courses

CHE 540, PME 540

Prerequisite

Graduate Student or At Least Junior