| 08.00 - 08.30 |
Welcome, Presentation
of the Speakers |
| 08.30 - 09.30 |
Regulatory
Requirements Applying to QA Units
|
| 09.30 - 10.30 |
Out of Specification
(OOS)
|
| 10.30 - 10.45 |
Break
|
| 10.45 - 11.45 |
Failure Investigation
|
| 11.45 - 12.45 |
Validation of
Analytical Procedures
|
| 12.45 - 13.30 |
Lunch
|
| 13.30 - 15.30 |
Workshop I
- Supervision of Contract
Manufacturers
- Risk Analysis
|
| 15.30 - 15.45 |
Break
|
| 15.45 - 16.30 |
Presentation/Discussion
of Workshop Results
|
| 16.30 - 17.30 |
Self Inspection and
Auditing
|
| Day 2 |
|
| 08.30 - 09.30 |
Change Control System
|
| 09.30 - 10.30 |
Deviation Management
|
| 10.30 - 10.45 |
Break
|
| 10.45 - 12.15 |
Workshops II
- Annual Product Review
- Trending of QA Parameters
|
| 12.15 - 13.00 |
Lunch
|
| 13.00 - 14.00 |
Presentation/Discussion
of Workshop Results
|
| 14.00 - 15.00 |
Process Validation
and Equipment Qualification
|
| 15.00 - 15.15 |
Break
|
| 15.15 - 16.15 |
QA Involvement in R
& D/Documentation Control/Archiving
|
| 16.15 - 17.00 |
Final Remarks/Discussion |
