null EDQM Training Module 7: Control of impurities: CEP approach

CERTIFICATION OF SUITABILITY 07/07/2022 ON-DEMAND WEBINAR

This module covers in detail how to control impurities in active substances in the context of a CEP application. The presentation outlines how to build and justify an appropriate control strategy, not only for organic and mutagenic impurities but also for elemental impurities and organic solvents. Concepts are illustrated with concrete examples and applicable regulatory requirements are described. The recording includes a Q&A session.  

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Target audience 

The module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.

It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.

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Duration: 1 hour, 30 minutes.

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Other Events/Training Sessions

On-Demand Webinars

Suggested viewing and reading

The EDQM recommends participants watch and read the pre-training materials listed below before joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the webinar sessions.

Upcoming events
European Pharmacopoeia 04/10/22 ONLINE

CombiStats™ Training Webinars

Organs, tissues and cells 26/09 to 09/11/2022 Online

2nd training course on Quality Management for Tissue Establishments

EDQM 1-3 November 2022 Frankfurt, Germany

CPhI Worldwide & CEP One-to-One Sessions

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