09:15 |
Purpose and Objectives of Stability Testing; Nature of Stability Related Studies from Discovery to Launch and Thereafter
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
10:15 |
Coffee Break
|
10:30 |
Factors that Negatively Influence Stability-Related Quality Attributes
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
11:45 |
Global Stability Testing Guidelines, including Those for Storage and Distribution of Pharmaceuticals
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
13:00 |
Lunch Break
|
14:00 |
Stress Testing Best Practice, Characterization of Degradation Products, and Development of Stability Indicating Methods
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
15:15 |
Coffee Break
|
15:30 |
Essentials of a Successful Stability Testing Program - a) Establishment of Well-manned Stability Department b) Stability Testing Laboratory c) Sample Management and Testing Schedules d) Laboratory Information Management, Data Handling and Data Presentation e) Quality Metrics, Data integrity and QbD in relation to Stability Testing
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
16:30 |
Open Discussion on All Other Elements Contained in Regulatory Guidelines (like Test Parameters, Evaluation, Reduced Stability Testing Plans, etc.)
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
17:15 |
Closing Remarks and End of the Masterclass
|
