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Date: Mon, 9 Oct 2017 08:56:50 -0400
From: "FDA Regulations" <henryt@Food-Safety-Solutions.org>
Reply-To: "FDA Regulations" <henryt@Food-Safety-Solutions.org>
To:  <JOHN@TRANSOCEAN.COM>
Subject: Final Call: 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>FDA Laws and Regulations Governing Drugs, Medical Devices and Combina=
tion Products</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">Firms operating in an FDA-regulated industry sho=
uld be well-aware of and understand what laws and regulations apply to FDA-=
regulated products (e.g., food, drugs, biologics, cosmetics and medical dev=
ices including vitro diagnostics medical devices (IVDs)).<br /><br /> Join =
expert speaker <strong>Dr. David Lim</strong> in this <strong>live webinar<=
/strong>, <a href=3D"http://report.newsletters.email/t.js?s=3D59db71fe0c5f4=
47d2373979e&amp;u=3D38992357&amp;v=3D3&amp;key=3Ddcbc&amp;skey=3D7ebb1a8d65=
&amp;url=3Dhttps%3A%2F%2Fwww.audioeducator.com%2Ffood-safety%2Ffda-laws-and=
-regulations-governing-drugs-and-medical-device.html%3Futm_medium%3DEmail%2=
6utm_source%3DLim_100917%26utm_campaign%3DEFOOJC04_MB"><strong>FDA Laws and=
 Regulations Governing Drugs, Medical Devices and Combination Products</str=
ong></a><strong>, on Tuesday, Oct 10, 2017 </strong>at <strong>1:00 PM ET</=
strong>, where he will help you understand the laws and regulations governi=
ng food, drugs, biologics, cosmetics, combination products and medical devi=
ces including vitro diagnostic medical devices. David will share key statut=
ory and regulatory requirements as set out in the laws and regulations and =
will provide an overview of recent changes and amendments to important FDA =
regulations. Domestic and foreign firms, who are involved in either directl=
y or indirectly handling medical products (food, drugs, cosmetics, combinat=
ion products, medical devices and IVDs) will become aware of the regulation=
s that impact these products.</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" size=3D"2" color=3D"#000000">Overview of laws and =
regulations including recent amendments</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Definitions</font></l=
i>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Statutory requirement=
s</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Good manufacturing pr=
actices for food, drugs, biologics, and devices including IVDs</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Regulatory requiremen=
ts</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Investigational New D=
r&ugrave;g application (IND) and Investigational Device Exemption (IDE)</fo=
nt></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Differences between c=
osmetics and medical devices</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Common non-compliance=
 issues and consequences</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">FDA enforcement actio=
ns: recent cases</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">Best practices: dos a=
nd don&rsquo;ts</font></li>
<li><font face=3D"Arial" size=3D"2" color=3D"#000000">PASS-IT suggestions a=
nd recommendations</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"><em>Exclusive Q&amp;A session following t=
he live event to get advice unique to your situation.</em><br /><br /> Appl=
y "PM20" at check-out to get $20 off 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=
9db71fe0c5f447d2373979e&amp;u=3D38992359&amp;v=3D3&amp;key=3Ddcbc&amp;skey=
=3D7ebb1a8d65&amp;url=3Dhttps%3A%2F%2Fwww.audioeducator.com%2Ffood-safety%2=
Ffda-laws-and-regulations-governing-drugs-and-medical-device.html%3Futm_med=
ium%3DEmail%26utm_source%3DLim_100917%26utm_campaign%3DEFOOJC04_MB"style=3D=
"color: #f9417e;" ><u>CLICK HERE 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 get up to&nbsp;<strong>50% off<=
/strong>. To book, call&nbsp;<strong>1-866-458-2965.</strong><br /><br /> I=
f you prefer to order by phone, call&nbsp;<strong>1-866-458-2965</strong>&n=
bsp;and mention the promo cod&eacute;&nbsp;<strong>EFOOJC04_MB</strong></fo=
nt></td>
</tr>
<tr>
<td style=3D"padding: 10px;"><font face=3D"Arial, Helvetica, serif" size=3D=
"2" color=3D"#000000">Looking forward to your participation.<br /><br /> Th=
anks,<br /> <strong>Eric Merrill </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=
olor: #222222; font-family: 'Helvetica', 'Arial', sans-serif; font-weight: =
normal; mso-line-height-rule: exactly; font-size: 11px; padding: 0; table-l=
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  <tr style=3D"vertical-align: top; text-align: left; padding: 0;" align=3D=
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ak-word; -webkit-hyphens: auto; -moz-hyphens: auto; hyphens: auto; border-c=
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