Good Manufacturing Practice (GMP) and FDA Compliance Auditing

This intensive course is designed for professionals who need to audit manufacturing operations for compliance with Good Manufacturing Practice (GMP) standards, particularly those enforced by the U.S. Food and Drug Administration (FDA). It provides a detailed review of the Code of Federal Regulations (CFR), focusing on parts related to quality systems, documentation, facilities, and process control. Participants will learn how to conduct a compliance audit that mirrors an FDA inspection, identifying potential 483 observations and warning letter risks. The training emphasizes the critical role of GMP in ensuring product safety, quality, and efficacy in regulated industries like pharmaceuticals, medical devices, and food.