Forum Institut für Management GmbH

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

Forum Institut für Management GmbH
Online

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Wichtige informationen

Tipologie Seminar
Methodologie Online
Dauer 1 Tag
Beginn 31.12.2019
  • Seminar
  • Online
  • Dauer:
    1 Tag
  • Beginn:
    31.12.2019
Beschreibung

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.

Einrichtungen (1)
Wo und wann
Beginn Lage
31.Dez. 2019
Online
Beginn 31.Dez. 2019
Lage
Online

Zu berücksichtigen

· An wen richtet sich dieser Kurs?

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.

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Was lernen Sie in diesem Kurs?

e-Learning

Themenkreis

- 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