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5:45 pm |
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Subject: Engr Tech Leadrshp (Grad) (ETLS)
CRN: 21526
Lecture
St Paul: Owens Science Hall 251
Georgiann Keyport, Patrick Johnson
This course gives an introduction to the submission approval process, validation, manufacturing and quality requirements for combination products, drugs and biologics. Course topics will include a historic overview, the process to determine which FDA Center controls the regulatory process, applicable regulations and post-market approval practices for these products. Students will learn how the regulations and practices at CDER and CBER differ from CDRH. They will also learn how the FDA designated controlling center will shape the submission clearance/approval process, manufacturing control, and post-market requirements for a combination product.
3 Credits