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e-Learning: Stability testing in the ICH-region
e-Learning: Stability
Testing in the ICH Region
2018-12-16 2018-12-16 an Ihrem Arbeitsplatz Online

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.
Topics
  • 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

Aims and objectives

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.

Who should attend
This e-Learning programme addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good understanding of the requirements, data and challenges of stability testing.
Referenten
Ihre Referenten
Dr. Beatrix Metzner
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss


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