Method Validation and Transfer with focus on the new ICH Q2(R2) In-House Training

This in-house training will give practical examples from method validation and method transfer & pitfalls. Also Participants can ask questions interactively.

Overview

Method Validation In-house training will present Thenewdraft ICH guideline for method validationICHQ2(R2).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.

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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