Course Overview
The Person Responsible for Regulatory Compliance (PRRC) role was created under article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). However, the exact details of the role such as qualifications required, tasks, liability and administrative elements have been unclear for many.
Led by Anne Jury of Team-PRRC, this course will provide you with clarity on the role and all its responsibilities, so your organisation is compliant. You will examine key topics such as qualifications, appointment, registration, tasks, compliance and admin. It is designed for professionals who are a PRRC or considering becoming a PRRC for their organisation. It is also beneficial for management to attend so they fully understand the role of the PRRC.
SIA Latvia MGI Tech –
Well organized, trainer was so energetic. Majority of the content will be very useful in my daily work. Hope to attend other training courses too.
Skin Tech Pharma Group –
The course was really interesting and updated. It gives you a clear vision on the requirements and responsabilities of the position.
Biokit S.A. –
Complete and clear course on the PRRC role & responsibilities, with numerous and insightful collaborative discussions with speaker and attendees.
Skin Tech Pharma Group –
All good, very satisfied.
Skin Tech Pharma Group –
Very good experience. The trainer is a high-level expert.
SIA Latvia MGI Tech –
All good, satisfied
Reckitt Benckiser –
I’m new to this area and the opportunity to have a really in depth view, with lots of questions and discussion was fantastic.
Reckitt Benckiser (verified owner) –
Very beneficial in understanding the requirements on a deeper level and practical considerations.
Purple Surgical Manufacturing Ltd –
Excellent course, well presented and great to hear ideas from a range of different companies and how they approach different situations.
Reckitt Benckiser (verified owner) –
This course was very insightful and the use of real life examples really made you think. The course was very interactive and would definitely recommend to other companies if this is an area of interest for them
ANT Neuro B.V –
The requirements in Art. 15 and the guidance MDCG 2019-7 were further elaborated. The first-half of the course will help somebody who has no information on this. For people who have already read and understood the requirements, the second-half of the course might provide more insight with the quizzes and exercises.
RR Mechatronics Manufacturing B.V. –
Very informative, good trainer and enough information to find out what the Role of PRRC contains.
Owlpharma Consulting, Lda. (verified owner) –
The presenter Anne Jury was very nice, knowledgeable and provided a very interactive session. Loads of topics were mentioned, information that I could not access just by reading the regulation. definitely useful.