e-Learning: Stability Testing in the ICH Region - Stability testing for chemical and biological products in the ICH region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

This e-Learning will provide you with:
- knowledge of regulatory frameworks in Europe, the ICH region and the US;
- an understanding of the chemical, physical and microbiological factors influencing stability testing, as well as container closure systems and the transportation;
- in-depth knowledge of stability study requirements;
- the ability to apply bracketing and matrixing;
- knowledge of the data needed for extrapolation and defining the shelf life of a product;
- an understanding of the impact of changes on stability; and
- knowledge of the stability specifics of biological products.

This e-Learning was developed in January 2018.