Use QSIT to Your Advantage in FDA Device Inspections

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And knowledgeable experts expect the trend to continue in 2015.

What can you do to avoid becoming a statistic in the FDA's warning letter program?

Order the new management report
Use QSIT to Your Advantage
in FDA Device Inspections

It offers you a one-two punch of value and knowledge, relying on the combined expertise of Tim Wells, the man who literally wrote the book on QSIT inspections, and Jodi Scott of the law firm Hogan Lovells, an expert in QSR, adverse event reporting and field action requirements.

With this new report from FDAnews, you'll find out how the FDA determines your risk profile and learn important red flags that can alert you that an inspector is sniffing around for a specific problem.

You'll also get valuable takeaway points and pick up essential best practices, such as:

  • Understanding the differences between “top-down” inspections as prescribed in the QSIT manual, and the “bottom-up” approach FDA inspectors are using more and more
  • When devicemakers can rely on QSIT principles, and when inspectors may go “off book”
  • How to get top management involved with internal audits and compliance master plans;
  • Specific red flags the FDA looks for (Did you know an inspector’s request for shipping records is a red flag?)
  • The 5 types of QSIT inspections
  • Non-QSIT areas FDA also inspects

Use QSIT to Your Advantage in FDA Device Inspections also includes:

  • The Quality System Inspection Training (QSIT) Manual itself — full text
  • FDA’s Compliance Program Guidance Manual — 7382.845: Inspection of Medical Device Manufacturers

This is your opportunity to learn how to put QSIT to work in preparing for your next inspection.

Order Use QSIT to Your Advantage in FDA Device Inspections today!

Order Your Copy Today!

PDF Edition

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PDF Edition — $397

Table of Contents

  • Introduction
  • Focus on the 5 QSIT Areas
  • Top 5 Tips for Preparing for a QSIT Inspection
  • Key Procedures Before, During and After a QSIT Inspection
  • And More …

View the entire TOC

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