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Learning Content  
Learning Content The seminar covers the following topics:  Introduction and comparison of the old and new legal systems  Old legal system:  EU: MDD, AIMDD, IVDD …  
Get to know your trainer  
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…  
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…  
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 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…  
Target Group  
Target Group This seminar is designed for individuals who prepare for or actively participate in FDA inspections, e.g.:  Quality Management Representative (QMR)  Quality Managers …  
Requirements for Participation  
Requirements for Participation 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…  
Learning Content  
Learning Content The seminar covers the following topics: Legal framework and requirements of the FDA  Procedure of FDA inspections  Preparation for FDA inspections  Best…  
Learning Objectives  
Learning Objectives After the seminar you will be able to:    prepare for an FDA inspection, in particular,  identify gaps,  prepare the documentation, and  brief…  
Get to know your trainers  
After studying biomedical engineering and completing further training as a regulatory affairs manager, Katharina Keutgen spent many years working in development and regulatory affairs for…  
Results 1311 until 1320 out of 1352
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