Pharmacopoeial compliance testing - EU edition MasterClass

 In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question and answer sessions.

10-11 May, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

Pharmacopoeias play a major role in laying down quality standards for the manufacture and control of medicines in Europe and worldwide. These quality standards mostly cover active pharmaceutical ingredients and excipients both, in their original state and in the form of pharmaceutical preparations.

In this training course you will learn how to deal with requirements of individual and general monographs and how to apply general chapters. In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question and answer sessions.

Detailed information will be provided on impurity control, including nitrosamines and elemental impurities and on the correct use of pharmacopoeial reference standards. Delegates will also be informed about the use of alternative analytical procedures and about aspects of harmonization between pharmacopoeias.

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Who should attend?

This live online training addresses employees and managers from quality control labs as well as colleagues working in Quality Assurance and Regulatory Affairs. Assessors and inspectors from regulatory authorities may also be interested.