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Public webinars

In Vitro Diagnostics

IVDR Readiness

– Prepare for the changes in the new IVDR*

*IVDR - EU In Vitro Diagnostic Medical Device Regulation

Online webinar - 8 June 2020


Content

  • What are the main differences compared to the IVD (in vitro diagnostic medical devices directive)?
  • How do I establish a road map to be compliant?
  • Specific items that need my attention?
  • What are the timelines regarding product compliance?
  • How do I prepare my quality system to be in compliance? Additional requirements?
  • Feedback loop between Risk management, Performance evaluation and Post-Market Surveillance?
  • What is my responsibility as subcontractor/contract manufacturer towards a legal manufacturer?

Course description:

After this 2-hour webinar you will be better equipped to tackle these questions. We’ll walk you through the key IVDR requirements and provide you with tools to establish a road map for your work towards IVDR compliance.

The requirements posed on specified roles such as importer, distributor and “legal” manufacturer will be discussed as well.

Finally, we will cover how the interrelation between performance evaluation, risk management and post-market surveillance can be demonstrated in your quality system.

Learning objectives

Completion of this course will give you the knowledge needed to assess applicable requirements for IVDR compliance.

Who should attend:

The course is suitable for persons involved in, or responsible for product development or regulatory/quality work concerning IVD-devices and who need to know the changes that comes with the implementation of the In Vitro Diagnostic Medical Device Regulation.

Need of prior knowledge/experiences

  • You should have good knowledge of the quality system within the Medical Device segment.
  • You should have at least 2 years of experience within the IVD/medical device industry.

 

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Course facts

Course no:
5816
Industry:
Medical Devices, In Vitro Diagnostics

Level:
Intermediate
CS/GMP region:
EU

Language:
English
Instructor:
Åse Ek
Katalin Holenyi
Symbioteq Kvalitet AB

Date:
8 June 2020  CANCELED


Time:
10.00 - 12.00 CET (Central European Time)

Price (excl. local VAT):

250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.

For in-house live webinar, contact us for an offer.


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/s) and audio capabilities (speakers or headphones).
We are using the easy-to-use application "GoToWebinar".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.

Cancellation policy for webinars:
Cancellations received less than 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% of the course fee.

If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.

In case of failure to cancel before the course, the course fee will be charged in full.


Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.