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United StatesPerson Responsible for Regulatory Compliance (PRRC) Training
Person Responsible for Regulatory Compliance (PRRC) Training will provide learners with clarity on the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and provide details on the qualifications and liabilities that exist for PRRCs.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
This course is an internationally accredited credential. The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.
Overview of our Person Responsible for Regulatory Compliance (PRRC) Training
What's covered on our PRRC Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- The Role of the PRRC in the context of Article 15 MDR/IVDR
- Comparison of the PRRC with their equivalent in other industries/regulations
- Qualifications required to become a PRRC
- Demonstration of Qualifications
- Non-EU Qualifications
- What is meant by “Relevant Experience”
- Custom Made Devices and the PRRC
- Job Description of the PRRC
- Appointment letter for the PRRC
- Task of the PRRC of a Manufacturer
- Task of the PRRC of an Authorized Representative
- Delegation of Tasks for PRRCs
- Outsourcing the role of the PRRC
- Knowledge management for the PRRC
- EUDAMED Registration
- Impact of the PRRC on the QMS
- QMS Documentation and the PRRC
- Interactions of the PRRC with the rest of the organization
- Auditing the role of the PRRC
- The Liability of the PRRC
- PRRC Liability at a National Level
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the practical knowledge and be able to:
- Establish an understanding as to why the role of the PRRC was introduced in the MDR and IVDR
- Identify the qualifications and relevant experience required to become a PRRC, how to demonstrate them and document the qualifications and relevant experience
- Discuss and implement the elements involved in the appointment of the PRRC (appointment letter, job description)
- Recognize the requirements of appointing a PRRC (Internal PRRC vs Outsourced PRRC)
- Understand the responsibilities of the PRRC of a manufacturer and the Authorized Representative
- Comprehend the requirements of registration of the PRRC on EUDAMED
- Understand the integration and interaction of the PRRC into the organization and the impact of the PRRC on the Organization’s Quality Management System (QMS)
- Understand the Liability of the PRRC
- Quality Assurance Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
- Management Representatives
- Top Management
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (6).
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
In order to successfully complete this course, each Learner will need to:
- Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
Prior to attending this course, learners must be informed that they are expected to have the following prior knowledge:
EU MDR or IVDR
- A good understanding of the EU MDR (2017/745) and/or EU IVDR (2017/746) requirements and their application.
ISO 13485
- Must have experience of working with ISO13485
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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What Our Learners Are Saying
4.6
Average Rating
33 global ratings
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The course provided me with a solid understanding of the PRRC role and how to implement the requirements into our non EU based organisation.
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Very happy with the course content and the delivery. Being able to complete sections in my own time is a huge advantage.
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Good PRRC overview course in general
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I really enjoyed the course, and the structure of the content was well suited for my learning needs.
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Very detailed content with a good mixture of both listening and reading elements to ensure full understanding.
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