Mutagenic Impurity Risk Evaluation – Technologies to Assist in Stepwise Approach to Assessment
Date: 18 June 2020
Time: 15:00 (BST), 16.00 (CEST), 10.00 (EDT), 7.00 (PDT) - 16:30
Tutors: Dr Andrew Teasdale
This free to attend webinar will look to present 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 will look to provide 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 will also examine the future of ICH M7 and reflect on recent challenges associated with N-Nitrosamines and their current and future impact.
Who should attend? Chemists / Analysts, Quality Assurance professionals, Regulatory Affairs, Directors / VPs with overall accountability
This webinar will be 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.
The webinar will last for approximately 90 minutes and starts at the following time:
3.00 pm UK
4.00 pm Central Europe
10.00 am East Coast US
We’d like to thank Anatune, LGC, Lhasa and Waters for their kind sponsorship of this presentation.