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 Click here for Select Course Listing |
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| Clinical Supplies and Research |
| A-6. GMP Requirements for Compliance Issues for Clinical Supplies |
- FDA Inspection Policy
- GMP Applications to Clinical Supplies
- GMP Interpretations for Clinical Supplies
- Change Control and Reporting
- Bio-Sample Retention Requirements
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Level: A
Approx. Time: 90 min. |
| A-11. Development and Technology Transfer Reports |
- FDA Recommendations
- Preparation and Contents of Development and Technology Transfer Reports
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Level: A
Approx. Time: 75 min. |
| A-19. Good Documentation Practice and Compliance Review for Research & Development |
- Development and Technology Transfer Supports
- Good Research and Development Documentation Practices
- Good Science Systems and Practices
- Research and Development Support for FDA Pre-approval Inspection
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Level: A
Approx. Time: 90 min. |
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