Medical Device FDA QSR & QSIT

Course details

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

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• 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

Course Programme

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