e-Learning: Stability
Testing in the ICH Region

• Module 1: Regulatory requirements
• Module 2: Factors that influence stability testing
• Module 3: Stability test requirements
• Module 4: Bracketing and matrixing
• Module 5: Shelf life and extrapolation - Challenges
• Module 6: Impact of changes on stability
• Module 7: Challenges for biotechnological products

Who should attend

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.

The e-learning format allows you to create your own schedule, pause and rewind the video at any time, and avoid being pressed for time. You will benefit from the long-term experience of the expert Dr Beatrix Metzner. Feel free to pose questions while completing each single or after having completed all seven videos.