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.
Course may only be taken once for credit
Click here for the Fall 2022 Class Schedule.