This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants receive information on the selection of sites by the EDQM, as well as indications on how to prepare efficiently for a GMP inspection, in particular with regard to obligations/communication ahead of time. An overview of the nature and distribution of GMP violations observed during EDQM inspections conducted in recent years is also provided. The recording includes a Q&A session.
Download the virtual training agenda.
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, 51 minutes
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- Introduction to the EDQM inspection programme by Oisin Daly
- How to prepare for an inspection - most common GMP deficiencies by Thomas Hecker by Cristina Baccarelli
Other Events / Training Sessions
- EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
- How to read a CEP webinar
- Sterile substance CEP webinar
- Everything you've always wanted to know about the certification (CEP) procedure
On-Demand Webinars
Suggested viewing and reading
The EDQM recommends participants watch and read the pre-training materials listed below before watching a training module. The materials will help participants familiarise themselves with some basic concepts and topics which are not covered in detail in the webinar sessions.
- European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.) - Duration: 27 minutes
- General concepts in the European Pharmacopoeia - Duration: 28 minutes
- How to participate in the elaboration of the European Pharmacopoeia - Duration: 24 minutes
- Find your way in the new Ph. Eur. Online platform: new features, advanced navigation and efficient searching - Duration: 51 minutes
- Find your way in Pharmeuropa – Duration: 12 minutes
- Find your way in the Knowledge database – Duration: 6 minutes
- Ph. Eur. Reference Standards: General Aspects - Duration: 22 minutes
- CEP at a glance

