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Medical Device FDA QSR & QSIT

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Introduction

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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 participate?

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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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How do we train and support you?

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In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

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SnapshotSnapshot

Course Code
LS023
Duration
2 training days
Public Price
Virtual Training: €795

(includes course documentation).

Delivery Mode
This programme is delivered by Classroom, Virtual Training, or In-Company training 
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    [parent_categories_slugs] => Array
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            [0] => life-sciences
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What Our Learner's SayWhat Our Learner's Say


Content and training was highly usefull and beneficial. Kevina shared a lot of important insights and showed profund experience in the subject matter. Just great! Thank you
Veronique A November 2, 2023
It was an interesting two days and good to hear input from colleagues in the wider team as we all have different background and job functions There was a lot of information to take in which, at times, made it difficult to follow and absorb - so perhaps some more exercises/discussion to help with taking in this information The course was quite intense so 2 days' of learning was just about right in terms of length
Jolade A July 18, 2023
Excellent 2 day course - would definitely recommend.
Diane D May 31, 2023
excellent for prep team to support for audit readiness. Great to have reassurance of the systems in place,
Elizabeth L May 31, 2023
Read more reviews

Medical Device FDA QSR & QSIT

Duration: 2 days **
Hide
  • 26 - 27 May 2025
    Location: Virtual Book Date

Medical Device FDA QSR & QSIT

Duration: 2 days
Virtual Training: €795
Hide
  • 26 - 27 May 2025
    Delivery: Virtual Training
    Location: Virtual
    Book Date