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To: fcsiz@chemaxon.com
Date: Fri, 19 Sep 2014 10:38:19 -0400 (EDT)
Subject: Exclusive Webinar On Good Practices for Computer Systems in FDA Regualted Environment
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e=3D"LINE-HEIGHT: 20px; COLOR: #333333; FONT-SIZE: 12px; TEXT-DECORATION:=
 underline" href=3D"http://holkoi.custhelp.com/rd?1=3DAvMe~wr1Dv8S~xb~Gv8=
G~yJpe7Uqfbn70tSWBj7~Pv9f&amp;2=3D29352">Widen your knowledge on <span st=
yle=3D"FONT-STYLE: italic; COLOR: #cc0000; FONT-SIZE: 12px; FONT-WEIGHT: =
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al Change Management Best Practices for Systems Regulated by FDA</span> D=
o not miss the
chance</a></td>
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<td height=3D"auto" valign=3D"top">
<table style=3D"BORDER-BOTTOM: #cccccc 1px solid" border=3D"0" cellspacin=
g=3D"0" cellpadding=3D"0" width=3D"100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px;=
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COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none=
; PADDING-TOP: 0px" class=3D"time" height=3D"auto" valign=3D"top" width=3D=
"460"><span>Instructor: <a class=3D"sub_head3" style=3D"CURSOR: pointer; =
TEXT-DECORATION: underline" href=3D"http://holkoi.custhelp.com/rd?1=3DAvM=
e~wr1Dv8S~xb~Gv8G~yJpe7Uqfbn70tSWBj7~Pv9f&amp;2=3D29353">Carolyn Troiano<=
/a></span><br />
<span>Date: Wednesday, October 8, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style=3D"TEXT-DECORATION: line-through">$199.00=
</span> &#160; $183 Live Session for one participant<br />
<span style=3D"LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live =
+ Training CD at <span style=3D"TEXT-DECORATION: line-through">$499.00</s=
pan> $424</span><br />
Offer valid till September 19, 2014</td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height=3D"auto" valign=3D"top">
<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%"><!=
--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px=
; PADDING-TOP: 10px" class=3D"content" height=3D"auto" valign=3D"top" wid=
th=3D"460"><span><strong>Webinar Description:</strong></span><br />
This course is intended to provide specific guidelines for coaching atten=
dees on the best practices for creating organizational change as it relat=
es to computer systems regulated by FDA. These include, but are not limit=
ed to system implementation, testing, validation, migration, integration,=
 upgrade and retirement.<br />
<br />
Computer system validation has been regulated by FDA for more than 30 yea=
rs, as it relates to systems used in the manufacture, testing, distributi=
on and management of a product in the pharmaceutical, biotechnology, medi=
cal device, animal health, tobacco and other regulated industries.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
The attendee will learn how to develop a standard approach to managing or=
ganizational change when users not only have to accept new processes, wor=
kflows and systems, but have to do so in a manner that complies with FDA =
guidelines for computer systems. In some cases, users will be new to the =
concept of validation and FDA regulation, and will have to be coached on =
how to follow the necessary procedures. This is true in the Tobacco indus=
try, where regulations are emerging, but it is also true in pharmaceutica=
l and related industries where IT staffing may not have the skills or tra=
ining required. It's important to look at what is going to change, what a=
re some of the threats and challenges, and what methods you can use to mi=
tigate these.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
The course will focus on the key aspects of organizational change managem=
ent, including best practices and principles for handling this key compon=
ent of project work in an FDA-regulated environment (i.e., the system "to=
uches" product during the manufacturing, testing or distribution of the p=
roduct, or during any other functional activity). The material will inclu=
de the various aspects of change management, including planning, executio=
n, assessment and feedback. The result will be a prescriptive approach to=
 helping teams and individuals reach a higher level of acceptance to chan=
ge.<br />
<br />
FDA guidelines are very specific in terms of how computer systems are to =
be managed, and each company should have a specific strategy and methodol=
ogy, along with a set of rigorous tactical processes and procedures that =
prescribe how organizational change should be managed.</td>
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</td>
<td height=3D"auto" valign=3D"top" width=3D"242">
<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%"><!=
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<td height=3D"19" valign=3D"top" width=3D"242"><!--DWLayoutEmptyCell-->&#=
160;</td>
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<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%" bg=
color=3D"#EEEDED"><!--DWLayoutTable-->
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<td valign=3D"top" width=3D"238">
<table style=3D"BORDER-BOTTOM: #afafaf 2px solid; BORDER-LEFT: #afafaf 2p=
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<tr>
<td height=3D"35" valign=3D"center" width=3D"218" align=3D"center"><a cla=
ss=3D"reg1" style=3D"FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; =
COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT=
-DECORATION: none" href=3D"http://holkoi.custhelp.com/rd?1=3DAvMe~wr1Dv8S=
~xb~Gv8G~yJpe7Uqfbn70tSWBj7~Pv9f&amp;2=3D29354">Register Now</a></td>
<td width=3D"10"></td>
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</td>
<td width=3D"4">&#160;</td>
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<tr>
<td height=3D"2"></td>
<td></td>
</tr>
<tr>
<td height=3D"auto" valign=3D"top" colspan=3D"2">
<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%"><!=
--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-LEFT: 10px" class=3D"content" height=3D"auto" valign=
=3D"top" width=3D"242"><span><strong>Who can Benefit:</strong></span><br =
/>
Information technology analysts, project managers, organizational change =
managers, business process engineers, QC/QA managers and analysts, clinic=
al data managers and scientists, analytical chemists, compliance managers=
, lab managers, automation analysts, computer system validation specialis=
ts, GxP training specialists, business stakeholders and individuals who a=
re responsible for computer system validation planning, execution, testin=
g, reporting, compliance, and audit. This webinar will also benefit any c=
onsultants, contractors or vendors providing products and services to the=
 life sciences industries and who are involved in computer system impleme=
ntation, validation and compliance.</td>
</tr>
</tbody>
</table>
</td>
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</tbody>
</table>
</td>
</tr>
<tr>
<td height=3D"auto" valign=3D"top">
<table style=3D"MARGIN-TOP: 10px" border=3D"0" cellspacing=3D"0" cellpadd=
ing=3D"0" width=3D"100%" bgcolor=3D"#DCE4FF"><!--DWLayoutTable-->
<tbody>
<tr>
<td height=3D"auto" valign=3D"top" width=3D"242">
<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%"><!=
--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-LEFT: 10px" class=3D"content" height=3D"35" valign=3D=
"center" colspan=3D"2" align=3D"left"><strong>Instructor Profile:</strong=
></td>
</tr>
<tr>
<td style=3D"PADDING-LEFT: 10px" class=3D"content" height=3D"auto" valign=
=3D"top" width=3D"197"><strong>Carolyn Troiano</strong><br />
IT/Business Leadership Professional,</td>
<td valign=3D"top" width=3D"45" align=3D"left"><a style=3D"CURSOR: pointe=
r; TEXT-DECORATION: underline" href=3D"http://holkoi.custhelp.com/rd?1=3D=
AvMe~wr1Dv8S~xb~Gv8G~yJpe7Uqfbn70tSWBj7~Pv9f&amp;2=3D29355"><img alt=3D"I=
mage" border=3D"0" height=3D"40" src=3D"http://www.onlinecompliancepanel.=
com/images/speakers/22466/carolyn_32_40.jpg" width=3D"32" /></a></td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height=3D"auto" valign=3D"top">
<table border=3D"0" cellspacing=3D"0" cellpadding=3D"0" width=3D"100%"><!=
--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10p=
x; PADDING-TOP: 0px" class=3D"content" height=3D"auto" valign=3D"top" wid=
th=3D"242">Carolyn Troiano has more than 25 years of experience in comput=
er system validation in the pharmaceutical, medical device, animal health=
 and other FDA-regulated industries. She is currently the ERP (Enterprise=
 Resource Planning) Program Manager at the City of Richmond, VA, where sh=
e is overseeing the implementation of a large, complex system that spans =
more than 40 agencies and is used by more than 4,000 City employees. <a s=
tyle=3D"CURSOR: pointer; TEXT-DECORATION: underline" href=3D"http://holko=
i.custhelp.com/rd?1=3DAvMe~wr1Dv8S~xb~Gv8G~yJpe7Uqfbn70tSWBj7~Pv9f&amp;2=3D=
29356">More...</a></td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height=3D"auto">&#160;</td>
</tr>
<tr>
<td height=3D"auto" valign=3D"top" colspan=3D"2">
<table style=3D"BORDER-TOP: #cccccc 1px solid" border=3D"0" cellspacing=3D=
"0" cellpadding=3D"0" width=3D"100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td style=3D"PADDING-LEFT: 10px" class=3D"content" bgcolor=3D"#FFFFFF" he=
ight=3D"34" valign=3D"center" width=3D"698" align=3D"left"><br />
<span style=3D"COLOR: #0066ff; FONT-SIZE: 16px; FONT-WEIGHT: bold">Upcomi=
ng webinar</span><br />
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