In this practical seminar, you will learn how to reliably implement FDA vigilance requirements – from assessing reporting obligations to timely submission. We will also show you how to cover both the EU and US markets simultaneously with an integrated vigilance system.
In just four hours, you will gain comprehensive knowledge of FDA vigilance, including the legal basis and relevant guidance documents. You will learn how to identify and evaluate reportable events reliably and how to report and document recalls and adverse events to the FDA in a legally compliant manner.
We have not yet received any written feedback on this seminar.
In this seminar, we will show you how to combine FDA vigilance requirements with your existing EU processes in an integrated system. You will benefit from best practices from numerous successful FDA reports and recall support, and save time and resources in the future through intelligent process design.
Our experienced FDA expert knows the typical pitfalls from real inspections and shares proven solutions that will save you costly warning letters. Instead of theoretical treatises, you will receive concrete instructions on when and how to submit MDRs and report recalls, as well as insider tips on FDA communication.
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Phone
+49 7531 94500 20
Contact Form
The seminar covers the following topics:
After the seminar, you will:
This seminar is designed for:
Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices is helpful.
A basic knowledge of English is advantageous to be able to follow the texts discussed in the seminar.
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 studied medical technology and business administration and has several years of experience in international medical device approval. After working for medical device manufacturers in regulatory affairs, she now supports customers at the Johner Institute with questions and challenges relating to international requirements for medical devices and their approval. As a lecturer, her objective is to present the requirements clearly and understandably and identify commonalities and recurring tasks, thereby making the regulatory effort more predictable.
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.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
