U.S. FDA Quality Systems Regulation (QSR) 21 CFR 820 Course

Agenda                                                                                                                                         For medical device organizations wishing to sell their medical devices into the US market  it is important to establish and follow the framework of 21 CFR part 820 – Quality System Regulation (QSR) for their medical device quality system. Such a system ensures that the products conform to applicable requirements and specifications.

The QSR  applies to a broad range of medical devices and  requires manufacturers to develop and follow procedures for each of the sub systems within their quality system in order to ensure high quality for that specific device they manufacture, using appropriate details and knowledge that is current state of the art.  

The Quality System Regulations are structured into 14 subparts. Each part regulates an individual aspect of the whole quality system and on this training programme we go through each of the sub systems over the two days 

• An overview of FDA 21 CFR Part 820
• Quality System Requirements -Management responsibility, Quality audit, Personnel
• Design Control
• Document Controls, Subpart E - Purchasing Controls 
• Identification & Traceability
• Production and Process Controls
• QSIT approach to auditing Production & Process Controls
• Acceptance Activities, 
• Nonconforming Product
• Corrective and Preventive Action
•  Labelling and Packaging Control 
• Handling, Storage, Distribution & Installation
• Records,
• Statistical Techniques

Learning Objectives                                                                                                     
Learners will receive the information, knowledge, understanding and practical skills so that they can implement their learning’s within their own contextual work environment in order to meet  their own specific competitive situations on the introduction and operation of FDA 21 CFR part 820 – Quality System Regulation.