(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.
Click here to see upcoming dates for this course.
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.
Since 1968, Oriel STAT A MATRIX has delivered billions of dollars of increased profitability by helping organizations drive revenue and reduce costs. Oriel STAT A MATRIX is a global leader in consulting and training related to performance improvement and regulatory compliance. It has helped hundreds of companies throughout the world effectively develop the potential from within their organizations to successfully integrate and deploy performance improvement principles and practices, and to meet organizational, regulatory, and strategic goals.
