This lecture-based, 2-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the 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 the FDA’s current Good Manufacturing Practices and their direct application to the manufacture and testing of a regulated biological product. This course also provides a perfect opportunity to fulfill the FDA’s cGMP annual training requirement.
Attendees will be able to:
· understand the purpose and impact of cGMP protocols and regulatory compliance
· recall the history of cGMP and the role of the 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
cGMP for (Bio)Pharmaceuticals is an elective course in the Document Management, Operations Management, and Quality Management certificate pathways.
This course will be available live online on:
February 24, 2021, 9:00-11:30am ET
March 10, 2021, 1:30-4:00pm ET
