Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass - EU edition

This Online Masterclass gives practical examples from method validation and method transfer and also lets participants ask questions interactively throughout the session.

27-28 November, 2024, Virtual

Time Zone: UTC/GMT+1/CET

Overview

Day 1: Method Validation with focus on the new ICH Q2(R2)

The new draft ICH guideline for method validation ICHQ2(R2) has been published for comment.Together with the new ICHQ14 guideline for method development, both guidelines represent a fundamental change of direction in method development and validation, e.g. implementation of ATP (analytical target profile). The WHO guidelines on transfer of technology in pharmaceutical manufacturing as well as the new draft ICH guidelines represent the new basis for the transfer of analytical methods.

Day 2: Method Transfer

The WHO guidelines on transfer of technology in pharmaceutical manufacturing as well as the new draft ICH guidelines represent the new basis for the transfer of analytical methods.

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RECOMMENDATION

Who should attend?

Quality control employees

Specialists and managers from the areas of R&D, quality control and analytical chemistry

 CMC specialists