Seminar FDA’s Quality Management System Regulation
Learn about the new regulation in detail to optimally prepare your quality management system
This seminar will help you to understand the FDA's new requirements for your quality management system (QMS). You will learn what changes there are with regard to harmonization with ISO 13485:2016 and how to implement them in your company successfully.
Registration for the seminar FDA’s Quality Management System Regulation
If you have any further questions contact us directly .
PS: Would you like another appointment? Get in touch with us! Or consider an In-house seminar .
Gain clarity on which elements your quality management system must contain in the future
You will learn about the requirements of the new Quality Management System Regulation (QMSR) in detail. We will show you
- how the QMSR is structured,
- how it relates to ISO 13485, and
- what the specific requirements are.
Since ISO 13485 is a large part of the QMSR's content, the seminar will discuss and analyze all ISO 13485 requirements. We will also highlight additional FDA requirements.
The seminar is, therefore, aimed at people who have little or no knowledge of ISO 13485 or who want to improve and deepen their existing knowledge.
"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."
Learn how to implement the FDA requirements in your company efficiently and on time
The seminar does not consist of purely frontal teaching sessions but lives from interaction and working through the requirements from the original text. Our experts will show you how to correctly interpret the regulatory and normative requirements and derive the necessary tasks from them.
Benefit from our many years of experience to streamline your quality management system
Our trainers have many years of experience and in-depth knowledge in the implementation, optimization, and auditing of various QMS and can, therefore, give you valuable tips on how to cleverly combine all the requirements relevant to you and implement them in a lean and even beneficial way.
You can find more information about the seminar and the schedule in the information sheet:
Further Information
- Historic background
- Scope of the QMSR
- Overview of the structure of the QMSR
- Understanding and implementing contents and requirements of the QMSR
- Differences between the QSR and QMSR
- the scope of the QMSR.
- the contents of the QMSR (Note: Since ISO 13485 makes up a large part of the QMSR, the discussion of the standard requirements takes up the main part of the time).
- the transition period.
- strategies for interpreting and implementing the contents of the QMSR.
- the differences between QMSR (Quality Management System Regulation) and QSR (Quality System Regulation).
- Quality Managers
- Management Representatives (“QMR”)
- Regulatory Affairs Managers
- Others, e.g., Top Management of small companies
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 seminare@johner-institut.de to find a solution.
Three days before the seminar, 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.
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.
Get to know your trainers
Andreas Kalchschmid-Lehmann is an expert in in-vitro diagnostic medical devices with more than 17 years of practical experience in molecular diagnostics. He is the author of the German book “ISO 13485 - Opportunity instead of a Hurdle” and has extensive experience in other QM systems, including ISO 17025, ISO 15189, and MDSAP. As a laboratory manager, he gained detailed knowledge of processes in a routine diagnostic laboratory. As a former quality manager, he knows how to successfully set up and maintain a QMS for IVDs. He also worked as a product specialist and lead auditor at a major notified body, where he evaluated technical documentation for IVDs and QM systems.
Claudia Volk has several years of experience as a quality and regulatory affairs manager in regulated environments, initially in food production and later as a management representative and PRRC for manufacturers of in-vitro diagnostic medical devices. In this role, she has set up, developed, and audited QM systems and implemented digital QM tools. At the Johner Institute, she supports our customers in setting up and developing their QM systems and training their employees.
Are you familiar with our in-house seminars?
We are also happy to offer you our seminars as in-house seminars. Either online or at your premises, as required.
Please feel free to contact us.
Back To Top
Datenschutz
Wir nutzen Cookies auf unseren Webseiten. Einige von ihnen sind essenziell, während andere uns helfen, diese Webseite und Ihre Erfahrung zu verbessern