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Learning Objectives  
Learning Objectives After the seminar, you will be able to:    correctly assign and apply the definitions and terms related to the validation of computerized systems and the regulatory…  
Target Group  
Target Group This seminar is designed for individuals who  are required to validate computerized systems in medical technology companies.  are required to review validation…  
Requirements for Participation  
Requirements for Participation The seminar is designed as a beginner's course for participants who have no experience with CSV and need to learn the basics (terms, activities).  
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  
Urs Müller works as a consultant at the Swiss Johner office and supports customers and projects in product development and the development of production equipment for medical technology, focusing on…  
Learning Content  
Learning Content The course covers the following topics: Becoming familiar with and interpreting the requirements of EN ISO 13485 Definition of relevant terms in EN ISO 19011:2018 Audit…  
Learning Objectives  
Learning Objectives After the course, you will be able to:  correctly interpret and apply ISO 13485 in detail. plan, conduct, and follow up on audits in a risk-based manner. evaluate conformity…  
Target Group  
Target Group This course is designed for individuals who plan and conduct audits of quality management systems according to ISO 13485 and wish to obtain a corresponding, recognized…  
Results 1081 until 1090 out of 1479
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