August 6, 2021CERTIFICATE OF COMPLETIONValerie CarsonCurrent Good Manufacturing Practices for Biopharmaceuticalshas successfully completed the course
Wayne Hamm, M.A. Course Instructor Biotility @ UF CERHB
Tamara C. Mandell, M.Ed. Director Biotility @ UF CERHB36483475
August 6, 2021
CERTIFICATE OF COMPLETION
Valerie Carson
Current Good Manufacturing Practices for Biopharmaceuticals
has successfully completed the course
Wayne Hamm, M.A.
Course Instructor
Biotility @ UF CERHB
Tamara C. Mandell, M.Ed.
Director
Biotility @ UF CERHB
36483475
Valerie Carson
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.
Skills / Knowledge
- 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
- Good Manufacturing Practices
- Good Documentation Practices
- Regulatory Compliance
Issued on
August 6, 2021
Expired on
August 6, 2024