09:00 - 17:00
Online
Workshop no 2 for training of PRRC – Person Responsible for Regulatory Compliance
This 3-day workshop on Person Responsible for Regulatory Compliance (PRRC) is an advanced training for those who are looking to acquire the knowledge to act as PRRC in their own organizations. Led by experts and leaders in the industry, the course will provide you with in-depth understanding of the technical documentation, essential requirements, classification, conformity assessment, clinical investigation and evaluation and post-market surveillance. In one word, everything that a PRRC should know. Register now!
At the end of this training, you will be able to have an in depth knowledge of the MDR/IVDR requirements, as well as the profession of PRRC. More specifically, you will learn how to appropriately check the conformity of the devices, establish verification which are proportionate to the risk class and the type of device, maintain the technical documentation and the EU declaration of conformity up-to-date, proceed with reporting and verify the post-market surveillance obligations.
Who should attend :
- Medical device manufacturers management
- Staff that will be responsible for regulatory compliance
- RA manager, RA director, QA manager, QA director
- Professionals preparing for the MDR/IVDR
To attend this workshop, you must have completed Beginners workshop (or have relevant experience – to be evaluated by course instructor)
Schedule:
| Day 1 | 10:00 – 10:50 —– Essential requirements – Janette
10:50 – 11:00 —— coffee break 11:00 – 12:00 —– Technical file – Theory – Roland 12:00 – 12:30 ——Technical file – Exercises – Roland 12:30 – 13:30 —– Lunch time 13:30 – 14:30 —— Labeling – theory – John Webster 14:30 – 14:45 —— coffee break 14:45 – 15:45 ——- Labeling – cases study – John Webster 15:45 – 16:30 —– Panel Q&A – Closing words |
| Day 2 | 10:00 – 10:45 – Classification – MDR – Theory – Janette
11:00 – 11: 45 Classification –– MDR – Exercises – Janette 11:45 – 12:00 Coffee break 12:00 – 12:45 Classification – IVDR – Theory – Louise 12:45 – 13:45 Lunch break 13:45 – 14:45 Classification – IVDR – Exercises – Louise 14:45 – 15:00 Coffee break 15:00 –15: 45 Conformity assessment – Theory – Bassil 15:45 – 16:30 Conformity assessment – Exercise – Bassil 16:30 – 17:00 Panel Q&A – Closing words |
| Day 3 | 10:00 – 11:30 Clinical Evaluation – Theory – Louise
11:30 – 12:00 Clinical Evaluation – In practice – Helen 12:00 – 13:00 Lunch break 13:00 – 14:30 Clinical Investigation – Theory – Janette 14:30 – 15:00 Clinical Investigation – In practice – Helen 15:00 – 15:15 Coffee break 15:15 – 16:00 Panel Q&A – Final closing words |
Pricing:
- For Norway Health Tech members: NOK 10 000
- For members of other clusters and incubators: NOK 11 000
- For non-members: NOK 14 000
There are limited spaces on the training, so sign up now if you want to secure your spot (and commit to participating).
You can also sign up for information, but you will not have secured a spot. But we will know you are interested in regulatory training and send you information on regulatory training from Norway Health Tech Academy.
If you have any questions, please contact our Regulatory Advisor Kami Faust.
Norway Health Tech Academy is supported by Innovation Norway
Register