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Regulatory Essentials in Health Tech: Person Responsible for Regulatory Compliance

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This on-demand session summarises the most important elements for a Person Responsible for Regulatory Compliance (PRRC) to consider when carrying out 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 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

Inhalt

  • 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

Trainer

Karri Airola
Karri Airola
Senior Expert, Regulations, Quality & Training
karri.airola@labquality.com

”I have more than twenty years of experience in 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 the 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 my 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.”

Zielgruppe

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

Nach diesem Training

  • 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.

Hinweis

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 training sessions by Labquality are also recommended, such as sessions on ISO 13485:2016 for QMS and ISO 14971 for Risk Management.

RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.

Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.

Stornierungen erfolgen immer schriftlich an: koulutus@labquality.fi.  
Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@labquality.fi meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.

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