GMP Fundamentals: History
After a history of tragic events that affected public safety, the current Good Manufacturing Practices (GMPs) were developed. GMPs are a set of regulations that uphold the Federal Food, Drug, and Cosmetic Act. It is important to look back at the history of these events, their effect on public health and the FDA legislation that was set in place to protect consumers. This On Demand course (part 1 of 11) is designed to be a fundamental introduction to Good Manufacturing Practices. Participants will increase their understanding of the History of GMP regulations, the regulatory process, and the concept of operating in a "state of control," with an emphasis on the regulation of pharmaceutical products.
Course Agenda
- Review the history of GMP and standard terms
- Learn the basics of regulatory requirements
- Explore GMP principles and the approach
Interactive Course: What to Expect
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.