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


Graduate Student or At Least Junior


Chemical Engineering Program Mechanical Engineering Program Pharmaceutical Manufacturing Program

Typically Offered Periods

Fall Semester Spring Semester Summer Session 1