|
No. |
Topic |
Summary |
Pages |
11091
| Regulatory Requirements Applying to Development and Manufacturing in Clinical Phases I-III | - | 38 |
11092
| Control of Process Changes Through Development and Comparability | - | 45 |
11093
| Qualification or Validation of Analytical Methods for Biopharmaceuticals | - | 39 |
11094
| Process Validation in Clinical Phases I-III | - | - |
11095
| GMP Inspections in Biopharmaceutical Production | - | 33 |
11096
| Manufacturing of Cell Banks (MCB,WCB) and their Characterization | - | 51 |
11097
| Quality Assurance for Biopharmaceuticals | - | 51 |
11098
| GMP-conform Process Development and Qualification | - | - |
11099
| GMP-requirements for Buildings and Rooms | - | 52 |
11597
| Case Study: Design, Construction and Qualification of a Pilot Vaccine Production Facility | - | 45 |
11598
| Case study: Process Transfer from Development to Commercial Manufacturing | - | - |
11599
| Cleaning and Disinfecting Aspects in biopharmaceutical Production | - | 53 |
11600
| Single-use Equipment during Transfer of Development Products - a Case Study | - | - |
11601
| Design and Implementation of a Multi Purpose Facility for Biotechnological Manufacturing | - | - |
11602
| Cleaning Validation for Biopharmaceuticals | - | 41 |
19-20 June 2013 