08:30 - 17:00
Meeting room Hagen 1 - Forskningsparken/Oslo Science Park
This is a unique opportunity to increase your knowledge in the regulatory area by one of the most renowned instructors in the Nordics, Mr Peter Sebelius from Gantus.
We have invited Peter Sebelius from Gantus to give a two-day course on a very hot topic in the regulative world; Risk management. The courses will be held in English and you will be given a diploma upon finishing.
As Mr Sibelius is in very high demand, we will have to charge the participants for the participation:
- Members of Norway Health Tech: 9000NOK
- Non-member: 11 000 NOK
Maximum number of participants: 12
Learning Goal and Contents
The learning goal is that participants should be able to effectively perform risk management work for non-complex medical devices according to the requirements of ISO 14971.
The major topics covered during the course are:
– Why risk management?
– Risk management tools incl. FMEA, P-FMEA and FTA
– Risk analysis
– Risk evaluation
– Risk control
– Overall residual risk evaluation, risk management report and production and post-production information
Delivery and What to Expect
Gantus uses modern teaching techniques based on the latest educational science. Courses are evaluated during and at the end of the course to maximize the result.
The learning goal of the course is broken down into learning objectives. The course is divided into sections, each with its own set of learning objectives. The learning objectives will address key questions relating to effective risk management systems and the ISO 14971 for Medical devices.
The course focuses on how to work and why certain things should be done, as opposed to simply teaching the requirements. The course is interactive and engaging. Interactive check-points at the end of each section ensures that participants have achieved the learning objectives and ultimately the learning goal of the course. There will be several workshops throughout the course that will allow participants to practice risk management.
Slides that contain only bullet points or long texts are kept at a minimum throughout the course. Participants will receive hard copies of the slides.
Upon completion of the course, a report will be compiled containing the course evaluation
If you’d like to participate, send an e-mail to Anita Moe Larsen at Norway Health Tech. We accept participants until two days before the course (due to printing of course material) or when full.
