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4 November 2021



2021 Webinar - Supporting more scientifically driven risk assessments under ICH Q3D: Elemental Impurities Data Sharing


EI Consortium for Q3D Webinar image

In this webinar, delivered in Portuguese, Lhasa Limited, Principal Application Scientist, Diego Gomes, and Spektra  Consultoria CEO, Mariah Ultramari covered how to conduct a step by step risk assessment according to the ICH Q3D guideline. The use of supporting information, such as databases, alongside a scientific rational is crucial to minimize analytical testing and understand the risks of contamination in each step of the manufacturing process. A high level of confidence and understanding in your overall risk assessment reflects on better regulatory acceptance when comparing to testing without appropriate scientific rational.

The main topics discussed were:

  • An introduction to ICH Q3D guidance – the move from heavy metal testing to ICH Q3D
  • Regulatory acceptance of ICH Q3D risk assessments
  • Step by step guide to ICH Q3D risk assessment – key point and tips
  • Use of supporting information to minimise testing
  • Use cases for Elemental Impurities Excipient database risk assessment

Please note, this webinar was delivered in Portuguese only. Please find slides and recordings below.

We are planning on holding a similar webinar in English at a later date. To register your interest, please email marketing@lhasalimited.org with your name and email address to be notified when an English spoken event for this topic is available.

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