CLR 520 - Regulatory Affairs & Quality Management

Credits: 3

In-depth study of laws, regulations, and guidelines pertaining to biopharmaceutical and device development, clinical research, and quality assurance in the U.S. Presents the US FDA application process for investigation and marketing of biopharmaceuticals and devices. Reviews practical techniques to comply with regulatory and quality requirements.

Repeat Policy:
Course may only be taken once for credit

Click here for the Spring 2025 Class Schedule.