The FDA QSR Companion - How to Survive and FDA QSIT Inspection

QARA Compliance Connection has announced the release of a new informational handbook on the FDA Quality System Inspection Technique. This handbook reviews the four major subsystems of the FDA QSIT in clear and easy to understand language, and serves as an ideal reference for compliance. The QSR Companion is intended to assist manufacturers of medical devices with compliance and understanding of the Quality System Regulation as it relates to FDA's Quality System Inspection Technique (QSIT).

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The QSR Companion - How to Survive and FDA QSIT Inspection.

This handbook is just one in a series of informational handbooks that QARA Compliance Connection offers. These handbooks were prepared for quick reference on specific areas of industry interest. Included in the collection are: Conducting Formal Design Reviews, Medical Device Regulation Basics, Cosmetic Regulation Handbook and Understanding ISO 9000:2000. These handbooks are a cost effective alternative for understanding FDA regulatory requirements and although stand-alone products, they also serve as great supplements to any training program. Visit their website at http://www.qaracc.com for a table of contents for each of the handbooks.

QARA Compliance Connection also offers a wide variety of highly effective quality system CD-ROM training modules on ISO 9001, FDA QSR, Design Controls and Internal Auditing. These modules are designed to reduce the time, expense and scheduling difficulties associated with off-site employee training and provide organizations with the scheduling flexibility and convenience they require. Visit their website at http://www.qaracc.com to review their FAQ page to understand what makes these modules unique and superior to anything currently on the market. These modules are used by many well known medical companies worldwide including Smith & Nephew, Medtronic, Integra Life Sciences, Soft Computer Consultants, Olympus America, Baxter Healthcare and more.

Contact: QARA Compliance Connection, Inc.

         Tel: (813) 784-8457
         Fax: (530) 690-8393
         Email: info@qaracc.com
         Website: http:www.qaracc.com