CGMP for Biopharmaceutical Drug Products (Live Online)

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

· 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 the FDA CGMP regulations as defined in 21 CFR 210, 211, and 600

Anyone who works in or is training in operations, quality assurance, quality control, or technical services

Attend the lecture, score >80% on the assessment, and earn the course badge (awarded via Accredible).