Quality Systems Inspection Technique (QSIT)
Manufacturing companies within the biomedical industry are subject to routine inspections of their quality systems by FDA. This course describes an FDA Quality System inspection by explaining the key objectives that an investigator will address when reviewing each subsystem. Topics in this course include: Procedure, Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), Production and Process Controls (P&PC), and Preparation. After completing this course, learners will be able to identify the key elements for meeting the Quality System Regulation requirements.
After this course learners will be able to recognize how to properly prepare for a quality systems inspection.