Content Day 1 | |
09.00 - 09.45 | Overview of Stability Testing |
09.45 - 10.00 | Discussion |
10.00 - 10.45 | The ICH and other Guidelines |
10.45 - 11.00 | Discussion |
11.00 - 11.30 | Break |
11.30 - 12.15 | Stability Testing for Drug Substances and Stress Testing |
12.15 - 12.30 | Discussion |
12.30 - 14.00 | Lunch |
14.00 - 14.45 | Stability Testing for Drug Products |
14.45 - 15.00 | Discussion |
15.00 - 15.45 | Stability Plans & Protocols |
15.45 - 16.00 | Discussion |
16.00 - 16.30 | Break |
16.30 - 17.15 | Validated Analytical Methods and Procedures |
17.15 - 17.30 | Discussion |
Content Day 2 | |
08.30 - 09.15 | Stability Testing for Existing Products and Line Extensions |
09.15 - 10.00 | Bracketing and Matrixing for Reduced Stability Testing |
10.00 - 10.30 | Discussion |
10.30 - 11.00 | Break |
11.00 - 11.45 | Evaluation of Stability Results - Statistical Considerations |
11.45 - 12.00 | Discussion |
12.00 - 12.30 | Evaluation of Stability Results, Shelf Life Prediction |
12.30 - 12.45 | Discussion |
12.45 - 14.00 | Lunch |
14.00 - 14.45 | Outsourcing of Stability Testing to Contract Laboratories |
14.45 - 15.00 | Discussion |
15.00 - 15.45 | Report Formats CTD and Major Authority requirements |
15.45 - 16.00 | Discussion |
16.00 - 16.30 | Break |
16.30 - 17.00 | Panel Discussion (Collected Questions) |