In this seminar, you will learn how to validate your computerized systems (e.g., ERP, compilers, or self-developed EOL testers) in a risk-based, fast, and regulatory-compliant manner and how to create the necessary documents so that you can confidently face future audits.
You will first learn about the regulatory requirements of ISO 13485:2016 and 21 CFR part 820 for validating computerized systems. We then illustrate the implementation of suggestions from various guidance documents for fulfilling these requirements using an exemplary CSV process based on ISO/TR 80002-2, which you can incorporate directly into your quality management system after the seminar.
I really enjoyed the seminar. The scope was good, and everything was covered. I also liked the practical examples. The presentation and additional documents will definitely help me improve our company's procedures. Thank you very much!
After the seminar, you will know:
During the seminar, our expert will show you how to apply CSV using concrete validation documents from projects that have already been completed. You will also benefit from useful, practical tips and learn about typical problems that arise during audits and how to avoid them.
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.
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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
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).
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.
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 verification, validation (CSV), and software development. Since completing his computer science degree, Urs has worked in the software development service sector, first as a test automation engineer/tester and later as a team leader in an engineering company focusing on medical device development. Quality-driven development is in Urs' blood, and he enjoys sharing his enthusiasm for it with colleagues and customers.
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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