$199.00
This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relating ...
This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relating to IND Definitions, Part 312-Subpart D about Responsibilities of Sponsors and Investigators, parts of 21 CFR Part 314 -NDA as it relates to clinical operations, and other essentials regarding cross functional readiness.
This course can be used alone or as part of the full curriculum.
| Credit Hours | NA |
|---|---|
| Method of Training | Online, asynchronous, self-paced eLearning |
| Average Learning Time | 60 minutes |
| Enrollment Period | 12 months |
| Accessibility | 24/7 access to all program materials |
| Demonstration | Four (4) free trial courses are available |
| Group/Employee Training | Request a quote |
| Final Assessment | Multiple choice; unlimited attempts |
| Digital Badge | Issued upon completion |
| Certificate | Encrypted PDF with validation QR barcode |
