ICH Q3E Impurity Guideline: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics
Informa


ICH Q3E Impurity Guideline: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics

Duration - 17 Minutes

Price - INR-2000 / USD-60
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About the course

A presentation of a leachable risk management approach which can cover both packaging and manufacturing sources of leachables to provide a comprehensive evaluation of potential leachables modelled on the familiar existing ICH risk management approaches of Risk Identification, Risk Analysis and Risk Evaluation to provide a series of process steps which can be used to lower the risk from leachables both during initial development and as part of a risk management approach through the product lifecycle

Speaker Profile

Jason Creasey

Managing Director
Maven E&L Ltd.




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