| 09.00 - 09.45 h |
Overview of Stability
Testing |
| 09.45 - 10.00 h |
Discussion
|
| 10.00 - 10.45 h |
The ICH and other
Guidelines
|
| 10.45 - 11.00 h |
Discussion
|
| 11.00 - 11.30 h |
Break
|
| 11.30 - 12.15 h |
Stability Testing for
Drug Substances and Stress Testing
|
| 12.15 - 12.30 h |
Discussion
|
| 12.30 - 14.00 h |
Lunch
|
| 14.00 - 14.45 h |
Stability Testing for
Drug Products
|
| 14.45 - 15.00 h |
Discussion
|
| 15.00 - 15.45 h |
Stability Plans &
Protocols
|
| 15.45 - 16.00 h |
Discussion
|
| 16.00 - 16.30 h |
Break
|
| 16.30 - 17.15 h |
Validated Analytical
Methods and Procedures
|
| 17.15 - 17.30 h |
Discussion
|
| |
|
| Day 2 |
|
| 08.30 - 09.15 h |
Stability Testing for
Existing Products and Line Extensions
|
| 09.15 - 10.00 h |
Bracketing and
Matrixing for Reduced Stability Testing
|
| 10.15 - 10.30 h |
Discussion
|
| 10.30 - 11.00 h |
Break
|
| 11.00 - 11.45 h |
Evaluation of
Stability Results - Statistical Considerations
|
| 11.45 - 12.00 h |
Discussion
|
| 12.00 - 12.30 h |
Evaluation of
Stability Results, Shelf Life Prediction
|
| 12.30 - 12.45 h |
Discussion
|
| 12.45 - 14.00 h |
Lunch
|
| 14.00 - 14.45 h |
Outsourcing of
Stability Testing to Contract Laboratories
|
| 14.45 - 15.00 h |
Discussion
|
| 15.00 - 15.45 h |
Report Formats CTD
and Major Authority requirements
|
| 15.45 - 16.00 h |
Discussion
|
| 16.00 - 16.30 h |
Break
|
| 16.30 - 17.00 h |
Panel Discussion
(Collected Questions)
|
