Advanced Seminar "FDA Inspection"

The seminar covers the following topics:

• Legal framework and requirements of the FDA 
• Procedure of FDA inspections 
• Preparation for FDA inspections 
• Best practice for supporting and following up on FDA inspections 
• Dealing with deviations 
• Differences between an FDA inspection and an ISO audit 
• Impact of harmonization with ISO 13485 on the FDA inspection method

After the seminar you will be able to:   

• prepare for an FDA inspection, in particular, 
  • identify gaps, 
  • prepare the documentation, and 
  • brief colleagues. 
• accompany/lead an FDA inspection on the manufacturer's side. 
• respond in writing to any observations made by the FDA and follow up on them.

This seminar is designed for individuals who prepare for or actively participate in FDA inspections, e.g.: 

• Quality Management Representative (QMR) 
• Quality Managers 
• Head of or responsible employees, e.g., from the following areas: 
  • Development 
  • Production 
  • CAPA 
  • Customer Complaints/Service 
  • Vigilance

Participants can easily follow this seminar even without any special prior knowledge. Feel free to bring your process descriptions to the seminar so that we can check their compliance. However, you can also participate without any preparation. 

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events. 

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance. 

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.