FDA-regulated organizations must establish and maintain a quality system appropriate for the specific medical device being manufactured and meet the requirements of FDA's Medical Device Quality System Regulation. QSIT is intended to increase manufacturer compliance, inspectional consistency, product quality, and the efficiency of the enforcement action review process.

Review guidelines for the preparation and management of quality system inspections conducted by the FDA. 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); and corrective and preventive actions (CAPA).

For a complete week of FDA regulatory training, combine this one-day interactive program with our Understanding FDA's Medical Device Quality System Regulation (2 days), Implementing an ISO 13485 Quality Management System (1 day), and Introduction to Process Validation (1 day).

Objectives

• Understand the purpose, benefits and objectives of FDA's QSIT.
• Plan and prepare for your FDA inspection.
• Understand FDA's statutory authority.
• Manage your inspection process.
• Follow up after your inspection.
• Understand FDA enforcement actions.

Topics

• Introduction to FDA's QSIT
• Statutory authority and the scope of FDA inspectional powers
• QSIT approach to inspections
• Major subsystems
• Management controls
• Design controls
• Corrective and preventive action
• Production and process controls
• FDA 483s

Who Should Attend

Recommended for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with FDA during inspections. Also valuable for anyone who needs to become familiar with FDA Quality System Inspectional Techniques (QSIT), especially those involved with management controls, design controls, corrective and preventive actions, and production and process controls, the four QSIT focus areas.

CEUs: 0.8
Number of Days: 1