This seminar will help you to understand the requirements of MDR/IVDR and ISO 13485 for purchasing and supplier management in detail and to apply them accordingly in your company.
Using practical examples and proven best practices, you will learn how to reliably implement regulatory requirements, minimize communication problems, and successfully overcome challenges such as delivery difficulties.
Dealing with suppliers poses major challenges for many companies: strict regulatory requirements, communication problems, and supply bottlenecks often lead to high risks for quality and compliance. This seminar offers a comprehensive overview of all relevant aspects of supplier management, from the purchasing process and supplier selection to continuous monitoring and evaluation.
The seminar was easy to understand and practical, even for participants without prior knowledge. It was particularly helpful that those with initial experience in purchasing or quality management systems could immediately deepen and apply what they had learned. An all-around successful and well-structured seminar!
This seminar will give you the knowledge and tools you need to meet all supplier management requirements efficiently. With tried-and-tested examples and valuable tips, you will learn how to set up a reliable supplier management system that complies with regulatory requirements and contributes to optimized collaboration with your suppliers.
The seminar includes numerous case studies and an open exchange of practical experiences. You will receive numerous tips on how to deal with delivery problems, for example. The practical approach enables you to apply what you have learned directly in your company to minimize risks and ensure smooth delivery processes.
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.
The seminar covers the following topics:
Introduction and basis
Practice of the purchasing process
Monitoring and evaluation
After the seminar, you will be able to:
This seminar is designed for individuals who (in the future) will take on one or more of the following roles:
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.
Dr. Bernhard Gerstenecker has a PhD in microbiology and has spent his entire professional life in the medical device industry dealing with all aspects of IVD systems. For around 25 years, he developed immunochemical reagents and test procedures, established and further developed QM systems, and worked on regulatory affairs requirements. In addition, he worked for ten years in the IVD medical device industry as a quality and regulatory affairs manager. At the Johner Institute, he supports our customers in outsourcing regulatory roles such as external QMR and PRRC, establishing eQMS solutions, reviewing technical documentation, and conducting internal audits.
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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