2020-2021 Graduate Catalogue Archived Catalogue
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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 Fall 2024 Class Schedule.
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