Regulatory Essentials in Health Tech – Session 14: Person Responsible for Regulatory Compliance


This session summarises the most important elements for a Person Responsible for Regulatory Compliance (PRRC) to consider when carrying their tasks. Obligations of economic operators, management responsibilities and essential processes for continuous improvement of quality management are revised. This session covers items that are additional to the previous sessions of the Regulatory Essentials in Health Tech training series and completes the qualification for employees assigned with the responsibilities of a PRRC.

The Regulatory Essentials in Health Tech training series consists of fourteen 2,5h webinar sessions.
Read more on the complete course page here.

 


 

SPRING 2022
Time: 17.5.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 13.10.2022
Place: Online
Price: 250€ + VAT 24%

 

Target Group:
Employees assigned with the responsibilities of a PRRC or other responsible related to quality management systems, regulatory affairs and quality assurance. Useful information also for start-up founders.

After this session, you:

  • Understand the obligations of the various economic operators
  • Know the roles and responsibilities of the PRRC and the management
  • Understand the importance of continuous improvement

Notice:
It is recommended to follow the entire training series of the Regulatory Essentials in Health Tech to gain essential knowledge on the regulatory landscape. Other courses by Labquality are also recommended, such as course on ISO 13485:2016 for QMS and ISO 14971 for Risk Management.

Trainer:


Karri:
”I have more than twenty years of experience from the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).

My responsibilities have also spanned design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of his career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”

 

CONTENT OF THIS SESSION:

    • Responsibilities and roles of the PRRC and the management according to the MDR and IVDR
    • Tools for continuous improvement: management reviews, internal audits, mock-audits, Post-Market Surveillance, trend analysis, etc.
    • Committing key employees and management
    • Audits by authorities or notified bodies
    • Managing the requirements in multiple markets
    • Communication to authorities

BILLING AND CANCELLATION POLICY 
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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