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

This online masterclass gives practical examples and requirements from method validation, analytical method transfer and pitfalls. During the training, the participant can ask questions interactively.

22-23 January 2024, Virtual

Time Zone: Eastern Daylight Time (EDT) - UTC−04:00

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