e-Learning: Stability Testing 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.