TAGUNGSMAPPE
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Die Veranstaltung umfasst folgende Beiträge:
|
Nr. |
Thema |
Kurzf. |
Folien |
11052
| Global GMP Requirements from Phase 1 to Scale-up and Transfer | - | 34 |
11053
| Important Documents in Pharmaceutical Development | - | 40 |
11054
| Analytical Development | - | 35 |
11055
| Parallel Sessions, (No.1 out of 3)
1) How to handle changes in IMP Development and Manufacturing
2) Stability Studies throughout the Development of a new Product
3) GMP in API Development
| - | - |
11056
| Packaging and Supply of Clinical Trial Materials | - | 31 |
11057
| Case Study: How to handle Deviations in an R&D Environment | - | - |
11058
| IMP-Manufacturing: how much Qualification and Validation is needed? | - | 31 |
11059
| Case Study:
How to implement a Cleaning Validation in Pharmaceutical Development
| - | 22 |
11060
| Outsourcing in IMP-Manufacturing and Control | - | 36 |
11061
| The FDA Pre-Approval Inspection (PAI) | - | 29 |
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