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 and gain a good overview on the important aspects that concern the challenges of stability testing in practice. Feel free to pose questions while completing each single or after having completed all seven videos.