PME 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.
Cross Listed Courses
CHE 540, ME 540
Prerequisite
Graduate Student or At Least Junior