The US FDA is a powerful enforcement and inspection authority. A successful US FDA investigation, as the audit of a company in the pharmaceutical sector is called, must be sought. Why? Consequences and escalation in the event of failure can be drastic. And they can only be corrected in a lengthy and cost-intensive process.
This is the topic, one of the German language specialist presentation offered by gempex at this year's Lounges is dedicated to:
FDA Warning Letter - Lessons-learned for GMP Manufacturers
Lounges 2025, Karlsruhe, 25.03.2025, 10 AM, Room 3
Participants can expect a mini-crash course on the topic of "FDA Warning Letters".
The speaker is Dr. Ralf Aubeck, Principal Consultant at gempex GmbH, who reports from more than 30 years in the chemical, pharmaceutical and biotechnology industries. His presentation will draw on his extensive national and international experience with FDA inspections in various roles - on the industry side, from the perspective of a consultant, translator and coach. Dr. Aubeck is also a certified GxP and GMP auditor and is registered with the FDA as a PCQI.
The presentation addresses common mistakes that are often made. What needs to be considered? What are the particular risks for the manufacturer? What tips and recommendations can be given? Further points are escalation levels of the FDA of investigative cGMP inspections, typical errors and misunderstandings, unexpected issues and finally possible prevention.
Anyone who would like to attend the lecture can register to visit the Lounges and use the code "Lounges-KA-2025-gempex" for free admission.
If you have any questions about FDA inspections, inspection readiness and inspection preparation, please contact Dr. Ralf Aubeck at contact@gempex.com.
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