(STAT A MATRIX: Edison, NJ) -- Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate manufacturer compliance with the FDA’s Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.
Understand exactly what FDA investigators will look for during establishment inspections that focus on the specific subsystems of management controls, design controls, production and process controls (P&PC), andcorrective and preventive actions (CAPA). Class discussions cover guidelines for the preparation and management of quality system inspections conducted by the FDA so you will be ready for your inspection.
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For a complete week of FDA regulatory training, combine this one-day program with the two-day programs: Understanding FDA's Medical Device Quality System Requirements and Understanding an ISO 13485 Quality Management System. To learn more about this course combo, select course code ZFF or click here.