Seminar PRRC - Person Responsible for Regulatory Compliance

Learning objectives

In this training you will learn in detail about:

•     The tasks and responsibilities of the PRRC
•     A detailed presentation, analysis, and interpretation of Article 15 MDR / IVDR
•     The required expertise of the PRRC
•     The advantages / disadvantages of joint responsibility
•     The advantages / disadvantages of an internal or external PRRC 
•     The effects on the organization and the quality system
•     Best practices for implementation e.g. job description
•     The possibility of delegating tasks
•     How to deal with conflicts

This seminar constitutes the basis for becoming a PRRC. We recommend further seminars in order to be able to cover the extensive area of responsibility:

•     Seminar on the basics of MDR / Seminar on the basics of IVDR
•     Seminar on ISO 13485

Contents and Programm Schedule

The requirements of the MDR and the IVDR for the PRRC are very similar. We show you exactly the differences and also cover the requirements of the IVDR.

We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.

The trainer

Alexander Thern is lead auditor for MDD 93/42, ISO 13485, MDSAP and MDR. For the Johner Institute he is the trainer for the seminar "Internal Auditor" and "Medical Device Consultant and Safety Officer" since 2015. He shares the common vision of lean QM systems that contribute to real quality improvement and more cost-effective development and production. Alexander Thern looks back on many years of consulting and auditing practice. He has been working for the Johner Institute since 2010. Alexander has lived in England and speaks fluent (British) English

Target audience

The seminar "PRRC" is mainly aimed at the following roles:

•     Safety Officer for Medical Devices (what does "promotion" to PRRC mean to me?)
•     Managing Director (how do you deal with the fact that your PRRC can block the release of your products?)
•     Quality Manager (who is the responsible in the end?)
•     Development Manager (what about your responsibility for the conformity of technical documentation?)
•     Regulatory Affairs Manager

Experience as a safety officer is helpful, but not a prerequisite.

Here you will find information on the next dates and how to register. If nothing to the contrary is noted in the table on the overview page, there are still free places