Medical Device FDA QSR & QSIT

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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 rende... Read More

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.

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What's covered?

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Day 1

  • Introduction to US FDA Quality System Regulation [QSR] : 21 CFR PART 820
  • Medical Device FDA guidance documents
  • An Introduction to QSIT
  • QSR Subpart A - General Provisions, Subpart B - Quality System Requirements
  • QSIT approach to auditing Management Controls
  • Subpart C - Design Control
  • QSIT approach to auditing Design Controls
  • QSR Subpart D - Document Controls, Subpart E - Purchasing Controls & Subpart F - Identification & Traceability
  • QSR Subpart G - Production and Process Controls
  • QSIT approach to auditing Production & Process Controls

Day 2

  • QSR Subpart H - Acceptance Activities, Subpart I - Nonconforming Product & Subpart J - Corrective and Preventive Action
  • QSIT approach to auditing Corrective & Preventive action
  • QSR Subpart K - Labelling and Packaging Control & Handling, Storage, Distribution & Installation
  • QSR Subpart M – Records, Subpart N – Servicing & Subpart O - Statistical Techniques
  • Preparing for an FDA Audit
  • Medical Device Vigilance for Manufacturers

Who should attend?

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  • QA personnel responsible for the design and implementation of Quality Management Systems to comply with FDA QSR requirements
  • QA personnel with responsibility for Quality Audit programmes
  • Manufacturing & Process Engineers responsible for FDA QSR compliance
  • R & D and Design Control personnel required to comply with FDA QSR
  • Senior Management who need to demonstrate commitment to, and active participation in the Quality System
  • All personnel who are involved in quality management systems

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Describe the FDA Quality System Regulation 21 CFR Part 820
  • Understand the FDA audit approach following the Quality System Inspection Technique (QSIT)
  • Appreciate the guidance documents provided by the FDA
  • Gain an insight into recent FDA enforcement action

Who are the tutors?

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Duration
2 training days
Course Times
9.00am - 5.00pm
Price
€850

(includes course documentation, lunch and refreshments).

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

What They SayWhat They Say

Course was well laid out and made very applicable, personal and accessible to each person on the course. The tutor was very engaging, approachable and friendly. Made everyone feel involved and made the course very interesting

– Denise Clarken, Quality Assistant, Heartsine Technologies Ltd

Medical Device FDA QSR & QSIT

Duration: 2 daysPublic Price: €850
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  • 27 - 28 Sep 2017
    Location: Dublin Book Date