Approved training courses

Course description

The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analysing and controlling GIs in their products.

This 4 week course will provide you with the latest updates on regulatory expectations, clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing.

On this course, you will:
- Examine in detail the ICH M7, EMA and FDA guidelines
- Review implementation strategies of the ICH guideline for new chemical entities and generics
- Explore common in silico systems used and evaluate their strengths and weaknesses
- Discover methods to assess potential mutagenicity impurities
- Discuss the In-Vitro and In-Vivo tests available to examine mutagenic impurities
- Gain the knowledge to implement a successful strategic MI analysis with minimal impact on development times

This course is led by Andrew Teasdale, PhD. Andrew has over twenty years’ of experience in analytical chemistry and quality assurance and has published a number of papers relating to GIs as well as presented at a number of conferences. He has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control. He also led sub-groups within both EFPIA and PhRMA during the development of ICH M7 and currently leads a team developing the addendum to ICH M7 which will provide definitive limits for common mutagenic reagents.

Features of this Online Academy course:
- 7 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- Revisit the content with unlimited access to all the materials for 2 months
- Access the discussion forum and interact with other students and the trainer
- Direct contact with the trainer through the forum during the 4 weeks the course is running
- Additional content such as slides available to download


On request from training provider

Additional info

This course will be running from Monday 21 May 2018.

Teaching method



4 weeks


On request from training provider

Training provider

Pharmaceutical Training International



+44 (0) 20 7017 7481

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