This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants will 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.
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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: 2 hours
Download the presentations
- Introduction to the EDQM inspection programme by Oisín Daly
- How to prepare for an inspection - most common GMP deficiencies by Thomas Hecker
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