Medical Device FDA QSR & QSIT

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.

Delivery Mode

  • Customised

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What's covered?

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?

  • 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?

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?

John Lafferty

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma Black Belt, Cert. Training & Continuing Education, Cert. Quality Management, is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry.  John joined SQT as a tutor in 2007.  Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and  Regulatory Systems.  John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting.

“It is great to be able to bring this knowledge and the experience gained from ongoing involvement with Life Sciences companies into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices.  As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

One of John’s greatest achievements in most recent years has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.

Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National University of Ireland, Galway with 10+ years experience working as a Microbiologist and 7+ years as a trainer, auditor and consultant, she has the expertise to deal effectively with both Cleanroom and Quality related issues. She is experienced in problem solving, reviewing and critically analysing documentation, investigating non-conformances, writing reports, meeting deadlines and working with various teams. She is skilled in dealing with human related issues and has an admirable way of interacting and engaging at an interpersonal level with people at all levels of the business. With the wealth of experience Kevina has accumulated to date working with many different life science companies both nationally and internationally, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively, to ensure understanding.

Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. Her main focus is on improvements rather than non-conformances, giving businesses a clear, objective insight into their current conformance status and constructive feedback on how to improve and ensure business goals are achieved successfully. Her interpersonal skills, allied with her excellent communication skills make her a very effective trainer. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way.

Kevina is engaging, enthusiastic and very passionate about her work. Confidentiality and professional impartiality are strong values and principles that she works to at all times.

How do we train and support you?

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.

Kevina O’Donoghue


Kevina O’Donoghue

  • TBC

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