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Quality System Regulation: Equipment and Facilities Controls Subsystem
This program includes guidance for determining compliance with the Quality System (QS) regulation, MDR regulation, Medical Device Tracking regulation, Corrections & Removals regulation, & the Registration and Listing regulation.
The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; one of those is the Equipment and Facilities Controls subsystem. The purpose of the Equipment and Facilities Controls (E&FC) requirements of the Quality System Regulation (QSR) is to ensure that adequate equipment and facilities are available and maintained for manufacturers to produce and store devices that conform to their specifications and reduce the potential for contamination of those products.
This webinar will provide an explanation of the regulatory requirements for facilities and equipment that must be followed by medical device manufacturers in the manufacture and storage of their products, beginning with an overview of QSIT and an in-depth review of the elements included in E & FC.
Why Should you Attend:
Participation in this webinar will enhance the attendees' understanding of the FDA's philosophy on inspections of quality systems and the requirements defined for manufacturing medical devices.
Objectives of the Presentation:
This session will discuss:
An overview of the Quality System Inspection Technique.
Equipment and Facilities Controls regulatory requirements.
Relationship of the Equipment and Facilities Controls subsection to the Production and Process Controls subsection of the Quality System Regulation.
Who can Benefit:
Use For Registration:
Nihar Ranjan Mohanty