Course/Product Description Title: FDAs Quality System Inspection Technique (QSIT) Metropolitan Area: Minneapolis Event Venue: TBD Address: Minneapolis, MN Contact Phone: 770-410-9441 Starting Date / Time: 3/19/2010  -  8 am - 5 pm EST Duration: 1 day Description: FDA-regulated organizations must establish and maintain a quality system appropriate for specific medical devices being manufactured, while simultaneously meeting the requirements of the FDA's Medical Device Quality System Regulation (QSIT). QSIT is intended to increase manufacturer compliance, inspectional consistency, product quality, and the efficiency of the enforcement action review process. Course Objectives 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 sub-systems of: Management Controls Design Controls Production & Process Controls (P&PC) Corrective & Preventive Actions (CAPA) 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. Course 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 the 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. Regulatory Course Bundles Available For a complete week of FDA regulatory training, combine this one-day interactive program with our Understanding FDAs Medical Device Quality System Regulation (2 days), Understanding an ISO 13485 Quality Management System (2 days), and Understanding FDAs Medical Device Quality System Regulation (2 day). Select from one of the following options: Boston, MA (January 2010) Edison, NJ (February 2010) Minneapolis, MN (March 2010) Los Angeles, CA (April 2010) Boston, MA (June 2010) Minneapolis, MA (July 2010) Licenses / Designations / Educational Credits: CEU All US States: 0.8 All Canadian Provinces: 0.8 About The Provider: Founded in 1968, STAT-A-MATRIX is the world's leading consulting and training organization dedicated to improving business processes, management systems, and quality and regulatory compliance. We offer ongoing consulting and training in every aspect of business process improvement. Our approach is a unique blend of concepts, methods, techniques, and tools designed to transfer skills and knowledge to your organization's personnel. Our distinct approach integrates quality, regulatory, and business management systems to help improve your bottom line. Price: $595.00 More Info: Contact Us For More Information Click Here For More Cities And Dates To order this product by check/invoice or credit card, enter desired quantity here >>> Qty:

Keywords For This Course:
FDA medical devices, QSIT