CLR 520 - Regulatory Affairs & Quality Management

Course Description: 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.

Credit Hours: 3

Corequisite Courses: None
Prerequisite Courses: None
Additional Restrictions/ Requirements: None
Course Repeatability: Course may not be repeated

ADDITIONAL COURSE INFORMATION

Equivalent Courses: None
Undergraduate Crosslisting: None
Additional Course Fees: None
Course Attribute: None

Click here for the Spring 2025 Class Schedule.