Quality Systems Inspection Technique (QSIT)

Manufacturing companies within the biomedical industry are subject to routine inspections of their quality systems by FDA. FDA Investigators audit four major quality subsystems, including: Management Controls, Design Controls, Corrective and Preventive Actions, and Production and Process Controls. In this course, the learner will prepare for an FDA Quality System Investigator by becoming familiar with the key objectives that an Investigator will address when reviewing each subsystem, as well as the ""top down"" approach to record review. The subsystem approach focuses on the elements that are key to meeting the requirements of the Quality System Regulation.