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 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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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

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

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

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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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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Download brochure

Snapshot

Course Code

LS023

Duration

2 training days

Public Price

Virtual Training: £695

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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