Screenshot of a red background.

Pharmaceuticals

Quality Systems Approach

About the Course

FDA is continuing to modernize its approach to GMP for pharmaceuticals and biologics, as initially outlined under the “CGMPs for the 21st Century” initiative. This online training course explains the basis for this significant shift in FDA’s regulatory approach to manufacturing practices, outlines what it means for the regulated industries, and provides examples of actions that FDA has already taken to implement its quality systems expectations.