2014 - Quality System Regulation, Subpart G: Production and Process Controls

Instructor: Les Schnoll
Description:
The Quality System Regulation (QSR) Subpart G defines the requirements for Production and Process Controls. The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; two of those are the Production and Process Controls subsystem and the Equipment and Facilities Controls subsystem, both of which are contained in 21 CFR 820 (Subpart G).
The purpose of the Production and Process Controls (P&PC) requirements of the Quality System Regulation is to ensure that manufacturers produce devices that conform to their specifications. Where any deviations from specifications could occur during manufacturing, process control procedures must describe the controls necessary to ensure the devices will conform to their specifications. Process control procedures also help to ensure consistency in manufacturing. 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 that must be followed by medical device manufacturers in the manufacture of their products, as well as the regulatory requirements for facilities and equipment, beginning with an overview of QSIT and an in-depth review of the elements included in P&PC and 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
Production and Process Controls regulatory requirements
Relationship of the Production and Process Controls subsection to the Equipment and Facilities Control subsection of the Quality System Regulation
Who can Benefit:
Regulatory Management
Regulatory Professionals
Executive Management
Legal Professionals
Quality Management
Quality Professionals
Compliance Management
Compliance Professionals
Register Now:
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