Good Manufacturing Practices

Learn the FDA's basic Good Manufacturing Practices regulations through readings, reference materials and handouts. Specific topics include the Food Drug and Cosmetics Act, the regulatory structure, the drug GMP, and state and federal requirements. Be prepared to review and respond to a FDA warning letter as a learning tool.

Course Number: BIOL-40000   Credit: 3 units

This course is part of the following Certificate Program(s):

• Clinical Trials Design and Management

• Quality Assurance and Control

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry