Only 2 Spots left on Medical Device FDA QSR & QSIT course

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Do you want to further your career in the MedTech Industry? There are presently only 2 spots left on the SQT Training course which starts 6th March and covers Medical Device FDA QSR & QSIT training.

  • Duration: 2 training days
  • Course Times: 9.00am – 5.00pm
  • Price: €850 (includes course documentation, lunch and refreshments).

About Medical Device FDA QSR & QSIT Training

Manufacturers of medical devices who intend to market their products in the USA are required to comply with the regulations set out in US FDA 21 CFR Part 820: Quality System Regulation. Failure to comply with any applicable provision of the QSR renders a device adulterated under section 501(h) of the Food, Drug and Cosmetic Act.  Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.

This course is designed not only to train participants in the QSR requirements, but to bring them fully up to date on the latest thinking and interpretations of the regulation using recent FDA warning letters and other information published by FDA. This course provides information on the Quality System Inspection Technique (QSIT) approach adopted by FDA inspectors when auditing Medical Device Manufacturers for compliance against the QSR.

This course brings compliance requirements to an understandable level. It uses discussion groups together with real life examples based on the tutors experience as a tool to ensure the learning is positive, fun and effective. Learners will receive the skills and awareness they need to implement their learning’s within their own specific work environment in order to overcome their own specific challenges.

About This Course

To register for this course, or to find out more click here.

This programme is available In-House and on certain Public dates


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