Orientation to GMP Compliance
Because FDA GMP regulations have a direct impact on how you do your job, you need insight on how they are applied and interpreted. This course illustrates how the Food, Drug, and Cosmetic Act is tied to Title 21 of the Code of Federal Regulations and how Good Manufacturing Practices (GMPs) are key elements in those regulations. Topics include key definitions, GMP focus areas, interpretation of GMPs, and enforcement actions. After completing this course, you will be able to recognize GMP regulations, basic GMP requirements, your roles and responsibilities for compliance, and the ways FDA enforces GMP regulations.