Zdrowie i gospodarka · 29.05.1998
Quality System Inspection Technique Meeting
The Food and Drug Administration (FDA) is announcing the following public meeting: ``Quality System Inspection Technique.'' The goal of the meeting is to obtain views and opinions from interested parties concerning a proposed new technique for conducting quality system inspections. This proposed technique could eventually replace the technique presently used when FDA conducts quality systems (good manufacturing practices) inspections of medical device manufacturers. The proposed ``Quality System Inspection Technique'' was developed by a group composed of the Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs staff, familiar with the Quality Systems Regulation and present inspectional processes, with input from the medical device industry. This meeting is part of the CDRH's ongoing reengineering effort to develop an inspection program covering the Quality System Regulation that results in more focused and efficient inspections. DATES: The public meeting will be held on Thursday, June 18, 1998, from 8:30 a.m. to 5 p.m. ADDRESSES: The public meeting will be held at 5600 Fishers Lane, conference rooms D and E, third floor, Rockville, MD 20857. FOR FURTHE