Inspections by the US FDA are a prerequisite for the approval, supply and marketing of pharmaceuticals in the USA. Here, it is important to prepare well for the special features in advance and to identify and eliminate possible weaknesses in the company.
Dr. Ralf Aubeck, Principal Consultant at gempex GmbH, will give a technical lecture on this topic at the Lounges in Karlsruhe:
US FDA inspections - Typical Pitfalls.
The presentation will take place on 04/19/2023, in VIP3000 Session 9, 3:00 pm in Room 7.
First, the lecture clarifies the fundamental question: "What is special about the US FDA?" Here, the differences to "typical" GMP inspections in the EU must be taken into account. On the basis of various examples of cGMP pitfalls, an illustration of the compliance problem cases experienced in practice and criticized by the FDA is given.
It is also important to use the time before the inspection. How a good preparation can proceed is shown. Various specific recommendations on behavior and concrete experience points during and after the inspection by FDA investigators are discussed. Finally, a pitfall prevention is presented, which unfortunately is rarely fully implemented in practice and yet would be so important and helpful!
- What is special about the US FDA?
- Examples of cGMP pitfalls
- Recommendations for the time before the inspection
- Recommendations during and after the inspection
- Pitfall prevention is more efficient
Numerous tips from practice for practice are given. A first step to familiarize yourself with the topic.
Interested parties are welcome to ask questions directly to the speaker after the presentation at booth D12 of gempex or contact the gempex expert team via contact@gempex.com.
This might interest you as well:
GMP Audits and Inspections