CHE 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

ME 540, PME 540

Prerequisite

Graduate Student or At Least Junior

Distribution

Chemical Engineering Program Mechanical Engineering Program Pharmaceutical Manufacturing Program

Offered

Fall Semester Spring Semester Summer Session 1