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<b>Training</b> </font>
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<p align="center"><b>Software Verification and Validation for Medical Device Manufacturers <p>
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This comprehensive full-day workshop covers the critical topics of software verification and validation.
Concepts and practices applicable to the following key areas are presented:
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<li>Software-based medical devices<p>
<li>Quality System software (e.g., CAPA Tracking Systems, Complaint Handling Systems, etc.)<p>
<li>Software-based manufacturing and production equipment.<p>
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Based on guidance documents published by the FDA and years of experience working with medical
device companies, this workshop provides practical recommendations for applying software verification and
validation techniques in a manner that is both compliant and cost-effective.
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Examples of procedures needed to comply with the software validation requirements of the
FDA Quality System Regulation and the FDA General Principles of Software Validation Guidance document are
discussed and provided. This workshop includes in-depth discussions of software verification techniques,
such as peer reviews, and software validation techniques that can significantly improve the effectiveness
of your validation testing.
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In addition to medical device software, validation of software development tools, 3rd party and
off-the-shelf software, manufacturing and Quality System software is also discussed.<p>
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This workshop can be tailored to the specifics of your product development process. As a result,
you can immediately identify areas of potential regulatory exposure. By applying the guidance and
suggestions in the workshop, you can minimize or eliminate any potential exposure and improve the
effectiveness of your verification and validation activities.</b>
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<p align="LEFT"><b>Topics covered in this workshop include:</b></font>
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<li>Regulations, Guidance, and International Standards<p>
<li>Software Verification Techniques<p>
<li>Techniques for Effective Peer Reviews <p>
<li>Software Validation Techniques<p>
<li>Testing Levels, Methods, and Types<p>
<li>Test Planning<p>
<li>Testing Measures<p>
<li>Common Testing Problems<p>
<li>Validation of Software Tools, Off the Shelf, and 3rd Party Software<p>
<li>Validation of Quality System Software and software-based process equipment <p>
<li>Summary and Action Plan <p>
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To help reinforce critical skills related to software verification, an interactive
exercise is included in the workshop.
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<b>Tailoring</b>
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This workshop can be tailored to meet your specific development environment. <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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