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Learning Content  
Learning Content The seminar covers the following topics: Regulatory requirements: 21 CFR Part 803 and 806 FDA definitions for reportable events and recalls FDA reporting deadlines and recall…  
Learning Objectives  
Learning Objectives After the seminar, you will:  be familiar with the legal basis and guidance documents of the FDA. be able to reliably identify and evaluate reportable events. be proficient…  
Target Group  
Target Group This seminar is designed for: Process owners and executives in the area of vigilance/QM PRRC (Person Responsible for Regulatory Compliance) Regulatory affairs managers with FDA…  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices is helpful.  A basic knowledge of…  
What happens after registration?  
What happens after registration? After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.   An invoice will be…  
How is the seminar conducted?  
How is the seminar conducted? 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…  
What happens if questions or problems arise?  
What happens if questions or problems arise? If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The…  
Get to know your trainer  
Margret Seidenfaden studied medical technology and business administration and has several years of experience in interna­tional medical device approval. After working for medical device…  
Johner Academy  
Education and training reinvented: With the Johner Academy, you will become a qualified contact person for regulatory questions.  
Authorized Representative Services & Regulatory Roles  
We support you in successfully expanding into new markets – as a legal manufacturer, PRRC, authorized representative, or in other regulatory roles.  
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