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<b>On-site Training for FDA Regulated Companies</b> </font>
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Developing software in compliance with FDA regulations inlcuding the <b>Quality System Regulation</b> (QSR) and
<b>21 CFR Part 11</b>, as well as <b>FDA Guidance documents</b> and applicable international standards such as
<b>ISO 14971</b> (Risk Management) and <b>ISO 13485 </b>(Quality Systems) can be challenging.
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These courses are unique in that they can help your staff understand and interpret the QSR, the Guidance
Documents, and the standards from a <b>software perspective</b> and in a manner that is consistent with
FDA expectations and industry practice. My extensive software development expertise and first-hand knowledge
of FDA expectations, can help your staff learn what is and is not required as well as how to be compliant
in the most cost-effective manner.
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<FONT FACE="Verdana" SIZE="3" Color=red><b>On-site Courses</b> </font>
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<LI><A HREF="../../training/fda/fda1daycourse.html">
<b>Software Development for Medical Device Manufacturers - One Day Overview</b>
</a></LI><br><p>
<LI><A HREF="../../training/fda/fda2daycourse.html"><b>Software Development for Medical Device
Manufacturers - Two Day Course</b></a></LI><br><p>
<LI><A HREF="../../training/fda/swvvmedical.html">
<b>Software Verification & Validation for Medical Device Manufacturers</b>
</a></LI><br><p>
<li><A HREF="../../training/fda/rootmedical.html">
<b>Root Cause Analysis for Software-based Medical Devices</b>
</a></LI><br><p>
<LI><A HREF="../../training/fda/risk1.html">
<b>Risk Management for Medical Device Manufacturers</b>
</a></LI><p>
<LI><A HREF="../../consulting/tea.pdf">
<b>Improving the Effectiveness of Medical Device Software Validation</b>
</a></LI><p>
<LI><A HREF="../../training/fda/part11.html">
<b>21 CFR Part 11 - Electronic Records and Electronic Signatures</b>
</a></LI><br><p>
<LI><A HREF="../../training/fda/csv.html">
<b>Computer System Validation - for Software Used in Manufacturing and Quality Systems</b>
</a></LI><br><p>
<LI><A HREF="../../training/fda/process.html">
<b>Process Validation for software-based Process Equipment</b>
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<P><b>Brown bag Seminars<p></b></font>
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Brown Bag Seminars are a collection of short, focused, informal seminars aimed at helping organizations improve
predictability, productivity, quality, and time-to-market. By presenting focused topics in a short (about an hour)
informal setting, your staff can learn new methods and techniques that can help them in their work without affecting
time-critical project schedules. For some topics, a more in-depth treatment is needed; full and half-day workshops are
available on-site and tailored to meet your specific needs.
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Brown Bag seminars can also be used as a forum for discussing software quality issues and for sharing ideas and experiences.
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<P><b>Seminar Topics<p></b></font>
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<li><A HREF="../../training/fda/bbswdevmedical.html">Overview of Software Development for Medical Devices</a> <p>
<li><A HREF="../../training/fda/bbriskmedical.html">Overview of Risk Management for Medical Devices</a> <p>
<li><A HREF="../../training/fda/bbpart11.html">Overview of 21 CFR Part 11 - Electronic Records and Signatures</a> <p>
<li><A HREF="../../training/fda/bbprocessval.html">Overview of Process Validation</a> <p>
<li><A HREF="../../training/fda/bbcsv.html">Overview of Computer System Validation</a> <p>
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<b>Tailoring</b>
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Each of the workshops and seminars above can be <b>tailored</b> to meet your specific needs and
all are based on the simple principle that real learning occurs when people are actively involved.
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By reviewing your Quality Manual and relevant SOPs, an assessment of your current Quality System and how
it meets (or doesn't meet) the regulations and standards can be discussed as part of the workshop.
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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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