By J. Mark Wiggins

Published in: CfPA Webinar

Published on:

This comprehensive 2-day course will provide an understanding, including practical examples of compliance with compendial requirements, as published by pharmacopoeias. The course includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF, Ph. Eur. and BP. A global perspective is presented, with consideration also given to the pharmacopoeias in other important countries. Details of the content, organization and use of the pharmacopoeias are presented, along with regulatory considerations and applicability of compendial requirements. There is a detailed exploration of the development and revision processes for compendial standards, with real-life case studies offered. Efforts toward compendial harmonization are described, with information on the activities of the Pharmacopoeial Discussion Group (PDG) and prospective harmonization of drug substance/product monographs. The course concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and – ultimately – compliance with the requirements in the pharmacopoeias.

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