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<b>Training</b> </font>
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<b>Computer System Validation - for Software-based Process Equipment
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Validating computers and software systems used by Medical Device Manufacturers can be a daunting and
time consuming task. This workshop can help your organization perform cost-effective Computer System
Validation based on the <b>FDA QSR</b> and the <b>General Principles of Software Validation </b> guidance
document. In this workshop, you will learn cost-effective techniques that can provide your
organization with the skills needed to not only be compliant, but be more efficient.</font>
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This workshop can be tailored to the specifics of your current Quality System. As a result, you can
immediately identify areas of potential regulatory exposure. By applying the techniques presented in
this workshop, you can minimize or eliminate any potential exposure and improve the effectiveness of
your process validation activities.</b>
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<b>Topics covered in this workshop include:</b></font>
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<li>Computer System Validation Overview <p>
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<li>Regulations and Guidance Documents
<li>Terms and Concepts <p>
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<li>Requirements Overview <p>
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<li>Third Party Software
<li>OTS Software
<li>Home-grown Software <p>
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<li>Validation Overview<p>
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<li>Test Planning
<li>Test Development
<li>Test Execution and Regression Testing
<li>Test Reporting <p>
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<li>Summary and Action Plan <p>
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<b>Tailoring</b>
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This workshop can be tailored to meet your specific needs.
<p>Call for details...
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<b>For further information,
<p>call Steve Rakitin at <font size="3" color=Red face="Arial">508.529.4282</font>
<p><font size="3" color=Black face="Arial">or e-mail him at
<a href="mailto:[email protected]"><b>[email protected]</a></b><p><br>
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Food for Thought and Predictable Software Development are trademarks of Software Quality Consulting, Inc.<br>
Copyright �2008 Software Quality Consulting, Inc. All rights reserved.<br>
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Updated September 2008</font></p>
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