Course Description

410.683 - Introduction to cGMP Compliance

Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribution of drugs, biologics and medical devices in the U.S. and internationally. In the U.S., they are codified at the federal level, in the FD&C Act and the CFR, and actively enforced by FDA. These regulations, however, only begin to describe the practices used in the pharmaceutical and biotech industries. Additional sources of insight and guidance include FDA's guidance documents and training manuals, industry trade publications, international compendia, and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and "best-practices" approaches, and FDA's current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.