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 Click here for Select Course Listing |
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| Part 11 and Other FDA GMP Initiatives |
| A-23. Electronic Records and Electronic Signatures |
- Comprehensive review of the regulations and interpretations for each subpart
- Includes module A-28
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Level: A
Approx. Time: 3 hrs. |
| A-28. Part 11 Guidance - Electronic Records and Signatures |
- Part 11 Guidance 8/2003
- FDA Enforcement Discretions for Selected Areas
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Level: A
Approx. Time: 30 min. |
| D-20. Process Analytical Technology (PAT) |
- Definitions and Scope
- Principles and Tools
- PAT Implementation Plans
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Level: A
Approx. Time: 20 min. |
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