About
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.
Lecturers
Krutarth Patel
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.
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
