CGMP for Biopharmaceuticals

This lecture-based, three-hour virtual course covers 21 CFR Parts 210, 211, and 600. Topics include Current Good Manufacturing Practices (CGMPs), regulatory compliance, and maintaining a culture of quality for the safe manufacture of biopharmaceutical drug products. Participants learn the core precepts of FDA’s Current Good Manufacturing Practices and their direct application to the manufacture and testing of a regulated biological product.

· Understand the purpose and impact of CGMP protocols and regulatory compliance
· Recall the history of CGMP and the role of FDA
· Recognize legislation, definitions, and critical components of CGMP in biological drug development
· Comprehend FDA CGMP Regulations as defined in 21 CFR 210, 211, and 600