Archived: Impurity challenges in 2019 – a reflection on recent events / guidelines and their potential impact.

Date: 06 February 2019

Time: 15:00 - 16:00 GMT

This webinar looked 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 was 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.

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