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2019 - New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
Date2019-05-23
Deadline2019-05-23
VenueOnline Event, USA - United States 
KeywordsNew ich q3d; Usp 232/233 implementation; Usp 233 validation
Topics/Call fo Papers
Elemental Impurities: The case for change
Regulatory status: FDA, ICH Q3D, USP 232/233
Scope of the new guidance on Elemental Impurities - related to ICH Q3D and USP Chapters 232 and 233
What drug products are within the scope of the guidance
Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
How risk assessment influences what testing is required
What documentation related to control of elemental impurities is expected by FDA
Implementation of the Guidelines
Which procedures can be used to demonstrate compliance
Analytical Procedures and how methods should be validated
What you should be doing now?
Regulatory status: FDA, ICH Q3D, USP 232/233
Scope of the new guidance on Elemental Impurities - related to ICH Q3D and USP Chapters 232 and 233
What drug products are within the scope of the guidance
Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
How risk assessment influences what testing is required
What documentation related to control of elemental impurities is expected by FDA
Implementation of the Guidelines
Which procedures can be used to demonstrate compliance
Analytical Procedures and how methods should be validated
What you should be doing now?
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Last modified: 2019-04-12 22:26:27