4 November 2021
2021 Webinar - Supporting more scientifically driven risk assessments under ICH Q3D: Elemental Impurities Data Sharing
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 email@example.com with your name and email address to be notified when an English spoken event for this topic is available.
Headline Event (shown first above featured)
- Introduction to ICH Q3D guidance_The move from heavy metal testing to ICH Q3D
- Supporting more scientifically driven risk assessments under ICH Q3D
- Supporting more scientifically driven risk assessments under ICH Q3D: Elemental Impurities Data Sharing_Webinar Recording