; e-Learning: Stability testing in the ICH-region
2021-11-30 2021-11-30 , Online Online, 390,- € plus tax Dr. Beatrix Metzner https://www.forum-institut.com/seminar/21122455-e-learning-stability-testing-in-the-ich-region/referenten/21/21_12/21122455-e-learning-stability-testing-in-the-ich-region_metzner-beatrix.jpg 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.

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.
This e-Learning was developed in January 2018.
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.

e-Learning: Stability testing in the ICH-region

e-Learning: Stability
Testing in the ICH Region

- e-Learning -

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback

Webcode 21122455

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JETZT Buchen

Speaker


Everything at a glance

Appointment

anytime

anytime

Period

Venue

Online

Online

Fee
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

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.
This e-Learning was developed in January 2018.

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.

Program

Modul 1 Regulatory requirements
  • ICH guidelines
  • WHO guidelines
  • Additional stability guidance documents
After having passed this module you know the regulatory requirements on stability testing by ICH, WHO and other specific guidelines.

Modul 2 Factors that influence stability testing
  • Climatic zones
  • 'Quality by Design' - Influencing factors
  • Stability studies - Possible changes
  • Container closure - Impermeable vs semipermeable
  • Transport
  • End user
After having passed this module you have a deep understanding of how climatic conditions, product parameters, changes, container closure systems and the end user can influence the stability testing.

Modul 3 Stability test requirements
  • Long-term, accelerated, stress testing
  • Photostability
  • In-use stability
  • Stability throughout life cycle
After having passed this module you know which tests and test-paramenters are required and you have received tips from practice.

Modul 4 Bracketing and matrixing
  • Designs
  • Bracketing
  • Matrixing
After having passed this module you can define bracketing and matrixing and have received examples to the designs.

Modul 5 Shelf-life and extrapolation - challenges
  • Definition of the shelf life
  • Data required
  • Extrapolation
  • Text conditions
  • Post approval
After having passed this module you can define shelf-life and have an understanding of the necessary data and the extrapolation-requirements.

Modul 6 Impact of changes on the stability
  • Relevant guidelines
  • Kinds of changes
  • Stability-indicating parameters
  • Examples
After having passed this module you are familiar with the regulatory background and have deepened your understanding of different kinds of changes and their influence on the stability.

Modul 7 Challenges for biotechnological products
  • Relevant guidelines
  • Challenges
  • Batch selection
  • Forced degradation studies
  • Extrapolation
  • Additional challenges
After having passed this module you know the specific regulatory stability-requirements of biotechnological products in contrast to chemicals.

Trailer

e-Learning: Stability Testing in the ICH Region

Here you can get a brief insight into the e-Learning Stability Testing in the ICH Region.

Principles

Principles

The e-learning programme 'Stability testing in the ICH-region' comprises seven didactic modules that include videos in which the expert Dr Beatrix Metzner shares her expertise with you. You can also download and print the corresponding presentation documents. Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge. Each module ends with an online-test. Once you have completed the seven modules and passed all the tests, you will be awarded a certificate, which you can print out directly.The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How does it work?

1. Register for an e-learning programme on our website. 2. You will receive an email with your login data for our learning platform. 3. Log in to start your e-learning programme. 4. Complete your e-learning modules at your own pace. 5. Finalise the modules with a multiple-choice test. 6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out. Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.

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Modules

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