Archived: Mutagenic Impurity Risk Evaluation – Technologies to Assist in Stepwise Approach to Assessment

Date: 18 June 2020

This free to attend webinar presented an overview of a systematic approach to the conduct of a mutagenic impurity risk assessment and examine how to align this to the requirements of ICH M7. At each step in the process it provided examples of the technology that is available to enable a consistent and thorough approach, looking at aspects such as in silico assessment, control options and the use of purge calculations, instrument technology, sample preparation and service providers. It also examined the future of ICH M7 and reflect on recent challenges associated with N-Nitrosamines and their current and future impact.

Who should view the recording? Chemists / Analysts, Quality Assurance professionals, Regulatory Affairs, Directors / VPs with overall accountability

This webinar was presented by Dr Andrew Teasdale, AstraZeneca. Andrew is the author of the ICH Quality Guidelines: An Implementation Guide  and tutor on the 2-day course: Practical management of impurities and development of effective and comprehensive control strategies.

We’d like to thank Anatune, LGC, Lhasa and Waters for their kind sponsorship of this presentation.


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