| 8.30 - 8.45 |
Welcome and Introduction
of Participants |
| 8.45 - 9.15 |
Introduction in GMP and
important GMP Guidelines
|
| 9.15 - 9.30 |
Personnel -
Qualification, Training
|
| 9.30 - 10.00 |
Quality Management and
Documentation Systems |
| 10.00 - 10.30 |
Break
|
| 10.30 - 11.30 |
Hygiene - Measures and
Monitoring for Production and Personnel
|
| 11.30 - 12.00 |
Requirements for
Buildings, Facilities and Utility Systems |
| 12.00 - 13.00 |
Lunch
|
| 13.00 - 13.45 |
Workshops for Groups of
Participants* |
| 13.45 - 14.15 |
Presentation and
Discussion of Workshop Results*
|
| 14.15 - 14.45 |
Manufacturing and
Packaging of Clinical Supplies |
| 14.45 - 15.15 |
Break |
| 15.15 - 16.15 |
Transfer of
Manufacturing Procedure to Production
Documentation - Validation - Product License |
| 16.15 - 16.30 |
Final Discussion |
