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Medical Devices

QSIT 2: The Management Controls Subsystem

About the Course

This is the second course in a series of FDA online training courses on the Quality System Inspection Technique (QSIT). Topics include management controls documents, quality policies and objectives, organizational structure, management representative, management reviews, quality audits and FDA 483. Learners will be able to identify the seven inspectional objectives associated with the management controls subsystem.