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cGMP for Biopharmaceutical Drug Products

October 3 @ 9:00 am - 12:00 pm EDT

|Recurring Event (See all)

One event on October 11, 2022 at 9:00 am

$150

Course Description

This lecture-based, three-hour virtual 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 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 the FDA CGMP Regulations as defined in 21 CFR 210, 211, and 600

Details

Date:
October 3
Time:
9:00 am - 12:00 pm
EDT
Cost:
$150
Event Categories:
,
Website:
https://biotility.research.ufl.edu/industry-courses/cgmp-pharma/

Organizer

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