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Elemental Impurities Risk Assessment, Analytical and other Aspects
Elemental impurities in drug products may arise from several sources. ICH guidance for industry Q3D Elemental Impurities contains recommendations for manufacturers on applying a risk-based approach to control elemental impurities and PDE.
- What is a risk-based approach?
- Should all elements be covered?
- How do we get the supporting information?
- What are the appropriate analytical methods and...Continue reading
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Issues to be covered
- Evolution of Elemental impurities requirements
- Elemental impurities in APIs, components and final products
- Analytical methodologies
- Approaches to prepare the risk assessments
- Workflows and Decision trees
- Life-cycle management – post risk assessment elemental impurities management
Who should attend
- Pharmaceutical and API R&D
- Quality Control
- Quality assurance
- Regulatory affairs
Benefits to the Participants
- Analytical, Quality and Regulatory compliance
- Streamlining the internal processes and avoidance the redundant work
About The Lecturer
Michael Pesachovich
Founder AequitaLab LTD. Michael (M. Pharm, Ph.D. Org. Chemistry, Registered
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