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Date: Tue, 10 Oct 2017 07:49:14 -0400
From: "FDA Compliance" <henryt@Food-Safety-Solutions.org>
Reply-To: "FDA Compliance" <henryt@Food-Safety-Solutions.org>
To:  <JOHN@TRANSOCEAN.COM>
Subject: Last call to register: FDA Laws and Regulations Governing Drugs and Medical Devices
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Audio Educator  - 2222 Sedwick Rd - Durham - NC -  27713

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<div p>&nbsp;</div p>
<center></center>
<div p>&nbsp;</div p>
<table border=3D"0" width=3D"100%%" cellspacing=3D"0" cellpadding=3D"0">
<tbody>
<tr>
<td style=3D"padding: 10px; padding-bottom: 0px;" align=3D"center"><em><str=
ong><font face=3D"Times New Roman, Times, serif" size=3D"5" color=3D"#f9417=
e"><u>Surviving the Wrath of the FDA: Avoiding FDA Criminal Liability for F=
ailing to Comply With the FSMA</u></font></strong></em></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial" size=3D"2" color=3D"#0000=
00"><br /><br />Good morning,</font></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Helvetica, sans-serif" si=
ze=3D"2" color=3D"#000000"><strong>The FDA&rsquo;s expansive new powers und=
er the Food Safety Modernization Act (FSMA) have made the ag&egrave;ncy inc=
reasingly aggressive during its food safety inspections and investigations<=
/strong>. Using criminal prosecution as a tool to ensure compliance with th=
e FSMA, the FDA has demonstrated its willingness to go after food company e=
xecutives and employees in a number of high-profile cases. At the same time=
, the FDA has granted itself almost limitless power to gain acc&egrave;ss w=
ithout a warrant to virtually any company r&egrave;cord during the course o=
f an inspection or investigation. <strong>Is your company prepared to handl=
e a vis&igrave;t from the FDA?</strong><br /><br /> Join our <strong>On-Dem=
and Webinar</strong> &ldquo;<strong><a href=3D"http://report.newsletters.em=
ail/t.js?s=3D59dcb3a83277667f5e5794b6&amp;u=3D38997973&amp;v=3D3&amp;key=3D=
110e&amp;skey=3D7a1c61c5fc&amp;url=3Dhttps%3A%2F%2Fwww.audioeducator.com%2F=
food-safety%2Fcompliance-with-fsma-01-21-2015.html%3Futm_medium%3Demail%26u=
tm_source%3Dstevens%26utm_campaign%3DE99NSANJ_MB"style=3D"color: #f9417e;" =
><u>Surviving the Wrath of the FDA: Avoiding FDA Criminal Liability for Fai=
ling to Comply With the FSMA</u></a></strong>&rdquo; with expert speaker <s=
trong>Shawn K. Stevens</strong> on <strong>Wednesday, October 11, 2017</str=
ong> (Available all day), to <strong>learn about the reach of the FDA&rsquo=
;s new powers and recent cases in which it has issued criminal charges</str=
ong>. Shawn will also discuss the standards under which you or your company=
 can be criminally prosecuted by the FDA, and what your rights are during a=
n inspection or investigation. </font></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><strong><font face=3D"Arial" size=3D"2" color=
=3D"#000000">Session Highlights</font></strong></td>
</tr>
<tr>
<td style=3D"padding: 10px; padding-top: 0px;">
<ul>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s expansive new powers to enforce the FSMA</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s power to go through your company&rsquo;s r&egrave;cords a=
nd computers</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s power to criminally charge food companies and employees</=
font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">Recent cases in which food company executives and employees have been pro=
secuted by the FDA</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">How to prepare your facility and employees for your next FSMA inspection<=
/font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">How to correct conditions in your facility that can lead to criminal pros=
ecution</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">How to prot&egrave;ct yourself from a criminal prosecution</font></li>
</ul>
</td>
</tr>
<tr>
<td style=3D"padding: 10px;"><strong><font face=3D"Arial" size=3D"2" color=
=3D"#000000">Agenda Details</font></strong></td>
</tr>
<tr>
<td style=3D"padding: 10px; padding-top: 0px;">
<ul>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">FDA regulatory requirements for prot&egrave;cting public health</font></l=
i>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">Criteria used by the FDA to identify organizations to inspect</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The scope and impact of the FDA&rsquo;s increased powers</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s purview under routine inspections</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s acc&egrave;ss to company r&egrave;cords</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">The FDA&rsquo;s expanding scope for enforcement</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">A detailed look at the Park Doctrine, or the responsible corporate office=
r doctrine</font></li>
<li><font face=3D"Arial, Helvetica, sans-serif" size=3D"2" color=3D"#000000=
">Recent examples of FDA enforcement of criminal felony charges</font></li>
</ul>
</td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Arial, Helvetica, sans-se=
rif" size=3D"2" color=3D"#000000"> Please use "<strong>PM20</strong>" at ch=
eck-out to get <strong>$20 off</strong> on registration.</font></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Helvetica, serif" size=3D=
"4" color=3D"#f9417d"><a href=3D"http://report.newsletters.email/t.js?s=3D5=
9dcb3a83277667f5e5794b6&amp;u=3D38997975&amp;v=3D3&amp;key=3D110e&amp;skey=
=3D7a1c61c5fc&amp;url=3Dhttps%3A%2F%2Fwww.audioeducator.com%2Ffood-safety%2=
Fcompliance-with-fsma-01-21-2015.html%3Futm_medium%3Demail%26utm_source%3Ds=
tevens%26utm_campaign%3DE99NSANJ_MB"style=3D"color: #f9417e;" ><u>CLICK HER=
E TO REGISTER</u></a></font></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Helvetica, serif" size=3D=
"2" color=3D"#000000">Attend in a group and sav&egrave; up to <strong>50%</=
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you prefer to order by phone, call <strong>1-866-458-2965</strong> and ment=
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</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Helvetica, serif" size=3D=
"2" color=3D"#000000"> Looking forward to having you onboard here. <br /><b=
r /> Thanks,<br /><strong>Henry T</strong></font></td>
</tr>
</tbody>
</table><table style=3D"border-spacing: 0; border-collapse: collapse; verti=
cal-align: top; text-align: left; width: 100%; background-color: #FFFFFF; c=
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