Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article 15? The understanding and implementation of these regulatory requirements is of paramount importance for every manufacturer of medical devices, regardless of their location globally.
Key facts about the seminar:
- Dates: Nov 23-24, 10 AM-2 PM NZST
- Platform: Online via Zoom
- Instructor: Alexander Thern
- Topics: PRRC responsibilities, Article 15 MDR/IVDR analysis
- Cost: NZD $1,100
When?
We cordially invite you to join our comprehensive PRRC seminar taking place on Thursday, November 23 and Friday, November 24 from 10 AM to 2 PM NZST each day. This 8-hour program, delivered online via Zoom, is designed to ensure you navigate these requirements confidently.
Who?
The seminar will be led by Alexander Thern, a seasoned expert and lead auditor for MDD 93/42, ISO 13485, MDSAP, and MDR, who is known for his vision of lean QM systems that drive real quality improvement and cost-effective development.
What?
In our seminar, we will dive into a wide range of topics, such as the tasks and responsibilities of PRRC, a thorough analysis of Article 15 MDR/IVDR, transitional provisions, and much more. It also offers insights into the practical side of implementing the PRRC role, such as conflict management, and the possibility of delegating tasks.
The seminar is designed to benefit Safety Officers for Medical Devices, Managing Directors, Quality Managers, Development Managers, and Regulatory Affairs Managers. It provides invaluable insights into the impact of the latest regulations on your role within the organization. No previous safety officer experience is required, just a keen interest in compliance and best practices.
How?
We are limiting the number of participants to 16 to ensure a conducive learning environment, so don’t delay securing your spot.
The cost of the seminar is NZD $1,100.
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
- Transitional provisions for manufacturers of legacy devices acc. MDCG 2021-25
- The required expertise of the PRRC
- Tasks of the PRRC at the Authorised Representative
- 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
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.
Contents and Program Schedule
|
Time |
Topic |
|---|---|
| 10:00 AM | Day 1 – Beginning of the seminar |
| 10:00 AM | Opening, introduction round, expectations |
| 10:30 AM | Legal basics: MDR Article 15, expertise Tasks of the PRRC:
|
| 11:25 AM | Break |
| 11:40 AM | Tasks of the PRRC:
|
| 2:00 PM | End Day 1 |
| 10:00 AM | Day 2 – Beginning of the seminar |
| 10:10 AM | Tasks of the PRRC:
|
| 11:00 AM | Break |
| 11:15 AM |
Best practices:
|
| 12:00 PM | Break |
| 12:15 PM |
|
| 1:15 PM | Questions (you haven’t asked yet) |
| 2:00 PM | Official ending |
The MDR and IVDR requirements for the PRRC are very similar. We will show you exactly what the differences are and also cover the IVDR requirements.
We limit the maximum number of participants to 16 to ensure learning success and to allow time for individual questions.
The trainer
Alexander Thern is a Lead Auditor for MDD 93/42, ISO 13485, MDSAP and MDR. For many years he has been a trainer for the Johner Institute for “Internal Auditor” and “Medical Device Consultant and Safety Officer”. He shares the common vision of lean QM systems that contribute to real quality improvement and more cost-effective development and production. Alexander Thern has many years of consulting and auditing experience. He joined the Johner Institute in 2010. Alexander has lived in England and is fluent in (British) English.
Register
Register today to gain confidence in navigating the era of PRRC! Stay informed, stay compliant. We look forward to welcoming you online!
