Impurity challenges in 2019 – a reflection on recent events / guidelines and their potential impact.
Date: 06 February 2019
Time: 15:00 - 16:00
Tutors: Dr Andrew Teasdale
This will look at key areas including
- Status of ICH M7 – a reflection on impact of Valsartan incident
- ICH Q3D – how widespread are Elemental impurities – reflection on implementation of Q3D for both new and existing products
- Other challenges
- Extractables and Leachables
- New modalities – a reflection on existing guidelines and their applicability – how a change in mindset is needed
This webinar will be presented by Dr Andrew Teasdale, AstraZeneca. Andrew is the author of the ICH Safety Guidelines and tutor on the 2-day course: Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies.