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Supporting more scientifically driven risk assessments under ICH Q3D: Elemental Impurities Data Sharing_Webinar Recording
In this webinar, delivered in Portuguese, Lhasa Limited, Principal Application Scientist, Diego Gomes, and Spektra Consultoria CEO, Mariah Ultramari cover 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 are:
- 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
