The final versions of ICH Q2(R2) Validation of Analytical Procedures, and Q14 Analytical Procedure Development, are now available on the ICH website. You can view the pdfs using the buttons below.

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MTS offers a new short course relating to these updates, ‘What’s New in ICH Q2(R2) and Q14?‘, which fully explores the updates to Q2 in terms of the additional information that has been introduced, and the expected benefits, the potential additional validation requirements and associated gap assessment, when compared to previous requirements, and also to provide an overview of the contents of Q14 and how this new guideline relates to Q2(R2).

Our existing courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘; and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘, have been updated to include all of the relevant content from both guidelines. They provide a complete treatment of analytical procedure lifecycle management in a pharmaceutical/biopharmaceutical analysis setting.

Visit our courses page for a full list of available courses and the schedule of currently available course dates.