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Course Description

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.

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Course Fee

$250 per participant

Audience

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

Contact Us

If you have questions or need assistance, please contact Wayne Hamm:

Phone: 386.518.2114

Email: whamm@cerhb.ufl.edu

 

Learner Outcomes

· 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
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