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<b>Training</b> </font>
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<b>Process Validation
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Performing process validation on computers and software used in Manufacturing can
be a daunting and time consuming task. This workshop can help your organization
learn to perform cost-effective Process Validation on complex equipment that
frequently includes <FONT Color=Red><b>embedded software</b></font>. In this
workshop, you will learn cost-effective techniques that can provide your
organization with the skills needed to achieve compliance in the most cost-
effective manner.</font>
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<p align="LEFT"><b>Topics covered in this workshop include:</b></font>
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<li>Process Validation Overview <p>
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<li>Regulations and Guidance Documents
<li>Terms and Concepts <p>
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<li>Validation Overview <p>
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<li>Process Equipment
<li>Quality System
<li>Third Party Software
<li>OTS Software
<li>Home-grown Software <p>
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<li>Process Validation <p>
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<li>Installation Qualification (IQ)
<li>Operational Qualification (OQ)
<li>Performance Qualification (PQ) <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 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>
<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 January 2008</font></p>
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