| 8.00 - 8.30 |
Welcome, Introduction,
Presentation of the Speaker |
| 8.30 - 9.30 |
GMP-Regulations and
GMP-Requirements for Change Control
- Europe
- FDA
- Harmonised requirements
|
| 9.30 - 10.30 |
Definition and
Differences
- Changes
- Deviations
- Change management
|
| 10.30 - 10.45 |
Break |
| 10.45 - 11.45 |
Changes and
Deviations in Production
- Implication on the processes
- Implication on the quality of
the product
- Assessment of the
changes/deviations
|
| 11.45 - 12.45 |
Changes and
Deviations in Quality Control
- Implication on the processes
- Implication on the quality of
the product
- Assessment of the
changes/deviations
- OOS as a deviation
|
| 12.45 - 13.45 |
Lunch |
| 13.45 - 14.45 |
Changes and
Deviations in other Departments
- Quality assurance
- Engineering
- IT
- Purchases etc.
|
| 14.45 - 15.00 |
Break |
| 15.00 - 16.00 |
Building up of a
Management System
- Building up of an overall System
- Incorporation of the management
- Incorporation of external
- SOP
|
| 16.00 - 17.00 |
Assessment of the
Changes in Respect to Registration
- Requirements of the EC
- Requirements of the FDA
|
| 17.00 - 17.30 |
Discussion |
