[Openflow-dev] Understand the critical aspects of computer systems to be scrutinized by FDA

[FDA C. T. <we...@em...>]

<p>Dear Colleague,</p>
<p>Your day is demanding enough, and training usually takes a back seat.</p>
<p>This session will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations.</p>
<p>It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.</p>
<p>By attending this live session, you will be able to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters.</p>
<p><a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/hcbx0Ce4FG0FlO0pnSQ0EW"><b><i>Trends in FDA Compliance and Enforcement for Regulated Systems</i></b></a><b><i> </i></b><b><i></i></b></p>
<p>Date: May 10, 2016<br> Time: 1:00pm - 2:00pm EDT US<br> Duration: 60 Minutes</p>
<p><a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/hcbx0Ce4FG0FlO0pnSR0EX">REGISTER NOW</a></p>
<p><b>Course Description:</b></p>
<p>During this course, you will understand FDA Compliance requirements and enforcement on computer system validation for emerging trends in patient safety, which includes following key points:</p>
<ul>
<li>Understand FDA compliance and enforcement as it relates to computer system validation</li>
<li>Understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA</li>
<li>Identify potential weaknesses and findings, as well as make recommendations for addressing and remediating them through risk mitigation</li>
</ul>
<p>&nbsp;<a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/hcbx0Ce4FG0FlO0pnSR0EX">REGISTER NOW</a></p>
<p><b>Your Expert Instructor:</b></p>
<p><b>Carolyn Troiano</b>&nbsp;has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries.&nbsp; <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/hcbx0Ce4FG0FlO0pnSS0EY">Read more</a></p>
<p>Thank you and we hope you can join us!</p>
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