This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants will receive information to facilitate efficient preparation for the inspection, in particular with regard to obligations/communications ahead of time. An overview of the nature and distribution of GMP violations observed during EDQM inspections in recent years will also be provided. 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, for example, newly graduated or early-career professionals.
Duration: 1 hour, 45 minutes
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- Module 8 : Introduction au programme d’inspection de l’EDQM, par Christina Baccarelli
- Comment se préparer à une inspection – Déficiences les plus fréquentes en matière de BPF, par Thomas Hecker
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