CGMP for Biopharmaceutical Drug Products (Live Online)

In this lecture-based, three-hour live online 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

Monday, January 23 (9am-12pm ET)

Wednesday, April 12 (1-4pm ET)

Friday, September 22 (9am-12pm ET)

Monday, December 04 (1-4pm ET)

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