The first part of this module explains how to build a good application for a new CEP and avoid deficiencies in order to facilitate and speed up the granting of a CEP.
The module is based on the recently revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality”, the use of SPOR OMS_IDs for companies and other essential documents such as the QOS template and “top 10 deficiencies”.
This module also addresses the preparation of sections 3.2.S.4.1 and 3.2.S.4.2 in line with CEP 2.0.
The recording includes a Q&A session.
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Target audience
The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.
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Duration: 1 hour, 30 minutes.
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