US FDA inspections are often dreaded, as the outcome is crucial - for better or for worse. Good preparation, execution and follow-up are therefore essential. Understanding the inspection process is often an important step in being able to prepare well and with reliability.
Anyone who wants to learn how to prepare, cope and manage US FDA inspections in pharmaceutical facilities efficiently and effectively is invited to attend the online seminar "Mastering FDA Inspections - Preparation and Best Practices" by Dr. Ralf Aubeck, Principal Consultant at gempex GmbH. What needs to be considered? What are the focus areas? Which documents are requested? The event will provide answers and valuable practical tips. The program is rounded off with a wide range of exercises.
The online workshop will take place on October 15, 2024 and is offered by the Forum Institut, Institut für Management GmbH, Heidelberg.
Important key points are:
- Regulatory requirements of the FDA
- Preparation in the company and advance briefing of employees
- What needs to be drawn attention to?
- Special FDA features
- Avoiding 483
- Handling warning letters
- Many exercises
Participants in the online workshop gain an understanding of the parameters, approaches and concerns of FDA inspectors. They will learn how to prepare, cope and manage FDA inspections. Practical examples illustrate the theoretical knowlege. Participants will also gain practical insights from numerous exercises.
The aim of the event is to enable participants to successfully manage an inspection and to provide them valuable assistance for the preparation.
For more information on the event, please see the program of the online workshop or visit the website of the organizer forum-institut.
If you have any questions about inspections, FDA or Inspection Readiness, please contact Dr. Ralf Aubeck at contact@gempex.com.
The technical article "FDA is coming" addresses the topic and is available at GMP-Knowledge.
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