The first part of this module will explain 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 will be 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 will also address the preparation of sections 3.2.S.4.1 and 3.2.S.4.2 in line with CEP 2.0.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
10:00-11:00 How to build a good new CEP application
11:00-11:30 Live Q&A session