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CGMP for Biopharmaceutical Drug Products (Live Online)

April 16 @ 9:00 am - 12:00 pm EDT

$250

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Course Description

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.

Learning Objectives

· 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

 

Learn more and register: https://biotility.research.ufl.edu/industry-courses/cgmp-pharma/

Details

Date:
April 16
Time:
9:00 am - 12:00 pm
EDT
Series:
Cost:
$250
Event Categories:
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Event Tags:
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Website:
https://biotility.research.ufl.edu/industry-courses/cgmp-pharma/

Organizer

Biotility
Phone
386-462-3181
Email
biotility@research.ufl.edu
View Organizer Website