WHEN

Thursday, 10th September

from 15:00 to 16:00 CET

WHEN

Thursday, 10th September

from 15:00 to 16:00 CET

JOIN THE WEBINAR!

JOIN THE WEBINAR!

CONNECTION

You will receive all the details by e-mail

CONNECTION

You will receive all the details by e-mail

Join this webinar to learn more about the Person Responsible for Regulatory Compliance (PRRC), as required by the MDR 745/1017 and IVDR 746/2017, and how to structure your quality agreements with critical suppliers, such as your distributors & importers.

Discover & Learn:

MDR/IVDR regulations require manufacturers to put in place quality agreements with distributors & importers and to designate a Person Responsible for Regulatory Compliance (PRRC) within their organization, or outsourced under certain conditions.

In this webinar, we will provide an overview on:

  • The Person Responsible for Regulatory Compliance

​

​

​

​

  • Quality Agreements with Distributors & Agreements

At the end of the webinar, we will make available special templates that will guide you on how to design a PRRC and to define its job description within your organization. We will also make available a template for quality agreements

Join this webinar to learn more about the Person Responsible for Regulatory Compliance (PRRC), as required by the MDR 745/1017 and IVDR 746/2017, and how to structure your quality agreements with critical suppliers, such as your distributors & importers.

Discover & Learn:

MDR/IVDR regulations require manufacturers to put in place quality agreements with distributors & importers and to designate a Person Responsible for Regulatory Compliance (PRRC) within their organization, or outsourced under certain conditions.

In this webinar, we will provide an overview on:

  • The Person Responsible for Regulatory Compliance

​

​

​

​

  • Quality Agreements with Distributors & Agreements

At the end of the webinar, we will make available special templates that will guide you on how to design a PRRC and to define its job description within your organization. We will also make available a template for quality agreements

PRRC & QA WEBINAR

PRRC & QA WEBINAR

FREE!

FREE!

All Right Reserved 2020 © Obelis Group

All Right Reserved 2020 © Obelis Group

Stay in touch

Stay in touch

Interested in other webinars? Let us know!

Interested in other webinars? Let us know!

Complying with the EU Market Regulations can be a daunting task to undertake on your own. Make sure you get all the information you need. 

We bring our experience and knowledge in the medical regulatory field, so don't miss the webinar!

Complying with the EU Market Regulations can be a daunting task to undertake on your own. Make sure you get all the information you need. 

We bring our experience and knowledge in the medical regulatory field, so don't miss the webinar!

31 YEARS OF QUALITY

SERVICE IN REGULATORY AFFAIRS

31 YEARS OF QUALITY

SERVICE IN REGULATORY AFFAIRS

Webinar: Person Responsible for Regulatory Compliance - MDR/IVDR

Webinar: Person Responsible for Regulatory Compliance - MDR/IVDR

SPEAKERS

SPEAKERS

Ajda Mihelcic

Deputy Manager

Publishing Department

Ajda Mihelcic

Deputy Manager

Publishing Department

10 September, 15:00 CET 

Save the Date!

10 September, 15:00 CET 

Save the Date!

Roland Gerard

Manager

Regulatory Affairs Department

Roland Gerard

Manager

Regulatory Affairs Department

PRRC Job Description

PRRC Job Description

WE WILL BE COVERING:

WE WILL BE COVERING:

Quality Agreements

Quality Agreements

- Job Description

- Designation method

- Tasks and responsibilities

- Cooperation between PRRCs (manufacturer & EAR)

- Job Description

- Designation method

- Tasks and responsibilities

- Cooperation between PRRCs (manufacturer & EAR)

- Job Description

- Designation method

- Tasks and responsabilities

- Cooperation between PRRCs (manufacturer & EAR)

- Job Description

- Designation method

- Tasks and responsabilities

- Cooperation between PRRCs (manufacturer & EAR)