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Impurity Challenges in 2019 – A reflection on recent events / guidelines and their potential impact.

06 February 2019
Event overview
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Webinars
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Impurity Challenges in 2019 – A reflection on recent events / guidelines and their potential impact.

Event overview

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 Quality Guidelines: An Implementation Guide and tutor on the 2-day course: Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies.

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Impurity Challenges in 2019 – A reflection on recent events / guidelines and their potential impact.

06 February 2019
Quote start icon

It was good. Never visited a Scientific Update webinar, but will get it on my priority list. Very good – like the set-up, flow and topics. Very interested in process development.

Organic Process Research & Development Webinar Delegate 2023

Thank you for the excellent webinar. I enjoyed the scientific content and the networking opportunities. I will definitely recommend this webinar to my colleagues.

The Formulation and Drug Delivery Congress Delegate

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Impurity Challenges in 2019 – A reflection on recent events / guidelines and their potential impact.

06 February 2019

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