The new QMSR is coming – are you prepared?
As a US manufacturer, you are familiar with the FDA requirements in 21 CFR Part 820. But do you know what the new QMSR requires? What does harmonization with ISO 13485 mean? How much additional effort will you have to put in
There is a great deal of uncertainty: you fear additional requirements, complex implementations, and high costs. There is no time to read up on it, but the FDA does not tolerate deviations. In the worst case, your products could be banned from the market
Learn how to solve this problem win two half-day sessions.
Work directly with the standard texts in many practical exercises. Our didactically excellent seminar makes complex requirements understandable. You receive immediate knowledge transfer and become independent of external consultants.
Benefit from our comprehensive ISO 13485 experience gained from countless projects, audits, and approvals. We know the leanest ways to comply with standards and give you the confidence to argue your case in audits.
Extremely competent and likeable expert. The seminar is well organized, good amount of content and flow of the training. The discussions on how processes can be carried out were very good.
We show you exactly what the FDA requires in addition to ISO 13485 and what really changes. You will learn in detail which few points the FDA wants to retain – without unnecessary extra work. This allows you to maintain an overview and avoid overregulation.
Tap into the European market with minimal additional effort. We show you the efficient path from QSR/QMSR to MDR/IVDR compliance. One QM system for the FDA and EU – saving you time, money, and resources.
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The seminar covers the following topics:
After the seminar, you will know:
This seminar is designed for people who have/will take on one or more of the following roles:
The seminar is aimed at people with little or no knowledge of ISO 13485. Therefore, participants can easily follow this seminar without any special previous knowledge.
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.
After completing her studies, Claudia Volk gained several years of experience as a quality and regulatory affairs manager in a regulated environment, initially in food production and later as a management representative and PRRC for manufacturers of in vitro diagnostic medical devices. In this role, she established, developed, and audited QM systems and implemented digital QM tools. At the Johner Institute, she supports our customers in setting up and further developing their QM systems and training their employees.
Andreas Kalchschmid-Lehmann is an expert in QM and in vitro diagnostic medical devices with more than 17 years of practical experience. He is the author of the book “ISO 13485 – Chance statt Hürde” (ISO 13485 – Opportunity instead of obstacle) and has relevant experience in other quality management systems, including ISO 17025, ISO 15189, MDSAP, and CFR 820. As a former quality manager, he knows how to set up and implement a QMS successfully. He worked as a product specialist and lead auditor at a large notified body. Today, as a widely recognized expert, he supports our customers and trains auditors for notified bodies as a lecturer in a certified course at the Johner Institute.
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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