IVDR Implementation and Audits

NEW
22 November 2022
IVD - Dispositivi Medico Diagnostici In Vitro

IVDR Implementation & Audits

English
Introduzione

IVDR implementation during the uncertain time of Corona Pandemic remains challenging.
Almost all organizations were forced to adjust/delay the IVDR program implementation. The whole process of Implementation became challenging due to compulsory home office rules, focus shift to Corona Tests, lack of notified bodies, Reference labs, and Audits (Internal and external).

During this course, we will present a case study on the IVDR implementation on a diagnostic device to fight COVID-19.

  • Introduction of IVDR 2017/746 – Highlights
  • Application to Notified Body
  • Quality Management System
  • Technical Documentation
  • Audits – Stage 1 and Stage 2 as well as Internal Audit and Critical Supplier Audits
  • Implementation Risks and Possible Solutions – as a Q&A session
  • Conclusions
  • R&D, RA and QM Employees from IVD Industry willing to get IVDR Certification
  • EU Rep
  • Quality Manager
  • Person Responsible for Regulatory Compliance
  • IVDR Project Manager

Participant experience
Basic knowledge of IVDR and ISO 13485.

Presentation and Q&A Session.

Docente/i
Krutarth Patel
Info

Krutarth Patel

Vice President QM / RA at R-Biopharm AG

Dr. Krutarth Patel works at R-Biopharm AG in Germany as a Vice President for QM / RA, he has more than 10 years of experience In Vitro Diagnostics with hands on experience with ISO 13485, ISO 9001 and MDSAP, Council Directives In Vitro Diagnostics IVDD 98/79/EC and IVDR. Dr. Patels had various positions during his professional career in IVD industries e.g. marketing & Sales, Clinical Affairs, Product Management, R&D, Production and as an Auditor.

This online training consists of 1 module:

22 November 2022 from 2:00 pm to 6:00 pm CET

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 465,00* (until 25 October 2022)

Ordinary: € 595,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Put all loose ends together and have broader pictures of complex process
Risultato atteso
Get an idea about possible risks and challenges
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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IVDR Implementation and Audits