Welcome address and Introduction to the Tutor

ICH Stability Guidelines and Worldwide Stability Requirements
Saranjit Singh, Professor (Retd.), National Institute of Pharmaceutical Education and Research, India

This part will cover ICH Q1, Guidelines by - FDA, EMA, MHRA, ASEAN, ANVISA, Quality Metrics

Development and Validation of Stability indicating Methods
Saranjit Singh, Professor (Retd.), National Institute of Pharmaceutical Education and Research, India

This section will cover Method Development, Customization, Risk-assessment, Robustness etc.

Break

Stability testing, Stress testing, Photostability and In-use Stability
Saranjit Singh, Professor (Retd.), National Institute of Pharmaceutical Education and Research, India

In this session, Study Design and Testing, Bracketing & Matrixing, Chambers, Forced degradation will be covered.

Management of Stability Program
Saranjit Singh, Professor (Retd.), National Institute of Pharmaceutical Education and Research, India

Risk areas, Data integrity, User Requirements, Reporting

Question/Answer Session

Closing Remarks and End of the Training Course