This seminar helps you prepare yourself and your quality management system (QMS) for an FDA inspection. You will learn about the FDA requirements and the inspection process in detail. That way, nothing will stand in the way of a successful inspection.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
First, you will learn about the FDA's general requirements for quality management systems and then which components of your QMS will be checked during an FDA inspection. This will enable you to identify deviations in advance and deal with them accordingly.
Thank you once again for the perfect cooperation and the really helpful training. We are already working intensively on the implementation.
Our expert will explain the exact procedure of an FDA inspection and provide you with numerous best practices for preparation, follow-up, and support. You will also benefit from valuable assistance and tips on possible scenarios and how to deal with deviations.
The seminar can also be held as an interactive in-house seminar. We tailor the presentations and exercises to your needs and prepare you and your colleagues individually for an FDA inspection. We directly integrate your company-specific processes into the seminar.
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+49 7531 94500 20
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The seminar covers the following topics:
After the seminar you will be able to:
This seminar is designed for individuals who prepare for or actively participate in FDA inspections, e.g.:
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.
Margret Seidenfaden supports our customers in challenges relating to international requirements and device approvals. She studied medical technology and business administration and focused early on QM and regulatory affairs. She is passionate about the diverse regulatory issues and overcoming the challenges that manufacturers face in international marketing. Before joining the Johner Institute, she was responsible for planning, implementing, and monitoring worldwide registrations.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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