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Medical Devices

Quality Systems Inspection Technique

About the Course

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