BIOT 650 - Regulatory Affairs and Quality Management in Life Sciences

Units: 3

Overview of the laws and regulations enforced by the Food and Drug Administration and other regulatory agencies related to the biotechnology, pharmaceutical, and medical device industries. Included is the U.S. legal regulatory system, Food, Drug, and Cosmetic Act and related laws, Freedom of Information Act, regulation affecting foods, drugs, biologics, veterinary products, diagnostics, and devices, FDA enforcement, product liability, and import/export requirements. Reviews the impact of quality systems and the functions, roles, and responsibilities on Quality Assurance and Quality Control.
Enrollment Restrictions: Enrollment is restricted to students who have been admitted to the Master of Biotechnology Program.