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<b>Brown Bag Seminar </b> </font>
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<font color=purple size=3 face="Verdana"><b>Overview of Part 11 <p>Electronic Records and Signatures </b></font> </p>
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Understanding and interpreting the requirements of the 21 CFR Part 11 Regulation can be a difficult and daunting task.
Many device manufacturers are <font color=red><b>caught unawares during FDA Inspections</b></font> when questioned about
compliance to Part 11. This workshop provides your staff with a basic understanding of the requirements of Part 11, the
concept of <font color=red><b>shared responsibility,</b></font> and provides concrete examples of how to meet the requirements
in the most cost-effective and efficient manner.
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This seminar provides an overview of the Part 11 Regulation and FDA expectations regarding compliance...
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<P><b>Audience:<p></b></font>
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<li>QA Managers
<li>Project Managers
<li>Manufacturing and Production Managers
<li>Software QA Managers
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<font size=3 face="Verdana" color=Red><b>About Brown Bag Seminars... </b></font>
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Brown bag seminars can be presented at your facility (New England area only) or remotely using WebEx...
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Most seminars also have expanded <A HREF="/training/on-site.html"><b>half or full-day workshops</b></a> that provide a
more in-depth coverage of the topic. These workshops often include hands-on exercises.
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Brown bag seminars and workshops can be tailored to your specific needs. 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 March 2008</font></p>
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