This module addresses 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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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, such as recent graduates or early-career professionals.
Duration: 1 hour, 30 minutes.
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