biologic gmps
course description
This four-hour course will highlight the main points of good biologic manufacturing practices defined in Title 21 of the Code of Federal Regulations, Part 600, focusing on quality. Additionally, 21 CFR Part 600 is the set of FDA regulations that help ensure the safety, purity, and potency of biological products administered to humans. Good documentation practices will be covered to ensure participants understand that documentation is essential for regulated industry compliance, including Part 11 Compliance for electronic records.
course specifics:
- Participant Cap - 30
- Delivery - Face-to-face or Virtual
- Course Length - Four (4) hours
- Printed Materials - Sent to company or college before delivery for them to print and disseminate