This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants 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 is also provided. The recording includes a Q&A session.  

 Download the virtual training agenda and schedule.

Target audience

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, such as recent graduates or early-career professionals.

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Duration: 1 hour, 45 minutes

Download the presentations

• Introduction to the EDQM inspection programme by Oisín Daly
• How to prepare for an inspection - most common GMP deficiencies by Oisín Daly

Other Events/Training Sessions

• EDQM Training Module 3: Impurity Control in the Ph. Eur.
• EDQM Training Module 4: Ph. Eur. Reference Standards