2024-10-13 2024-10-13 , online online, 390 € zzgl. MwSt. 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


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.
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.
Your benefit

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.

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 24122496

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Veranstaltung - 390 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end. Our general terms and conditions (dated 1 November 2021) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.

Veranstaltung - 390 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end. Our general terms and conditions (dated 1 November 2021) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Ihre Kontaktperson

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

+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


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.

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.

Your benefit

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.

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 (each about 10-15 minutes duration time). 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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