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<TITLE>Part 11</TITLE>
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<b>Training</b> </font>
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<b>Part 11 - Electronic Records and Electronic Signatures
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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 Part 11 compliance. 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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In addtion, we will discuss forthcoming changes to the Part 11 regulation...
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This workshop can help you immediately identify areas of potential regulatory exposure. By applying the
knowledge gained from this workshop, you can minimize or eliminate any potential exposure and
improve your overall compliance.</b>
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<p align="LEFT"><b>Topics covered in this workshop include:</b></font>
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<li>Part 11 Overview <p>
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<li>Regulations and Guidance Documents
<li>Terms and Concepts <p>
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<li>Responsibility for Meeting Requirements <p>
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<li>Manufacturer's Responsibility
<li>Clinician's Responsibility <p>
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<li>Validation of Part 11 Systems<p>
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<li>Test Planning
<li>Test Development
<li>Test Execution
<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. 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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