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Subject: Best Practices for Lean Documentation for Data Integrity, 21 CFR 11, Annex 11 & Computer Systems Validation
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 Content preview:  Validation and 21 CFR Part 11 Compliance of Computer Systems
    Your Gateway to Regulatory Compliance View Online About Us Webinars($10)
   Seminars Past Seminar Pictures 2-day In-person Seminar Best Practices for
   Lean Documentation for Data Integrity, 21 CFR 11, Annex 11 & Computer Systems
    Validation Click Here for More Details! Overview: Computer Systems Validation
    (CSV) also known as Software Validation is all-pervasive in the Life Sciences
    Industry. It is a requirement of all the predicate rules, as well as 21 CFR
    11 and Annex 11. However, unless one knows how to implement CSV, it is often
    very hard to detect the requirement for CSV, and very hard to determine what
    needs to be done, to meet domestic and / or international regulations or
   business continuity requirements. In addition, the FDA has stepped up 21 CFR
    11 inspections that include CSV. Read more... Date & Time Date: May 7th &
    8th, 2018 Time: 9:00 AM to 6:00 PM Download Seminar Brochure Venue Zurich,
    Switzerland Hilton Zurich Airport Download Registration form Angela Bazigos
    CEO, Touchstone Technologies Silicon Valley Angela Bazigos, is the CEO of
    Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences
    & Healthcare Industries. Experience combines Quality Assurance, Regulatory
    Compliance, Information Technology, Project Management, Clinical Lab Science,
    Microbiology, Food Safety and Turnarounds. Reserve your Seat Now Enroll Now!
    GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539,
    USA. Phone: +1-800-447-9407 Fax: 302 288 6884 www.globalcompliancepanel.com
    | Unsubscribe Copyright © 2017 GlobalCompliancePanel. All rights reserved.
    [...] 
 
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jHJlTQGjL0WgBzfua2j8CBW6l5SshXe4B9plc8GjHsRSne1neCzg8h91VXtpKX%3DUWYWT&amp;=
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ont-size:14px ; color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, =
sans-serif; line-height: 0;=22><span> <img alt=3D=22top teaser=22 border=3D=
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splay: block;=22 width=3D=22620=22 /> </span></td>
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r=22 style=3D=22padding: 0px; font-family: 'PT Sans', Helvetica, Arial, san=
s-serif; color:=23ffffff; font-size:16px; line-height:34px; mso-line-height=
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r=22 style=3D=22padding: 0px; font-family: 'PT Sans', Helvetica, Arial, san=
s-serif; color:=23ffffff; font-size:26px; line-height:34px; mso-line-height=
-rule: exactly;=22><span>Best Practices for Lean Documentation for Data Int=
egrity, 21 CFR 11, Annex 11 & Computer Systems Validation </span></td>
                                 </tr>
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N-->
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                                    <td align=3D=22left=22 bgcolor=3D=22=23=
21C5F5=22 style=3D=22padding-top: 20px;=22 valign=3D=22top=22>
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or=3D=22=23505050=22 style=3D=22padding: 10px 30px;font-size: 16px; line-he=
ight: 18px; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=23=
ffffff; margin: 0 =21important; =22 valign=3D=22middle=22><a href=3D=22http=
://seminar=2Eglobalcompliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJl=
TQGjL0WgBzfua2j8CBW6l5SshXe4B9plc8GjHsRSne1neCzg8h91VXtpKX%3DUWYAT&amp;_ei_=
=3DEq2tf9zs59idfPO1Sc_9BblkK0fQqwyLwsfc0q1LAjQAF4r6-eBC4L2V6oes36-lOz22Nu68=
a-NkTaRJePpb9bk=2E=22 style=3D=22font-weight: normal; font-style: normal; c=
olor:=23ffffff;=22 target=3D=22_blank=22>Click Here for More Details=21</a>=
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f; line-height: 0;=22><span> <img alt=3D=22bottom teaser=22 border=3D=220=
=22 class=3D=22img_scale=22 height=3D=2225=22 src=3D=22http://www=2Eglobalc=
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play: block;=22 width=3D=22620=22 /> </span></td>
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0=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22table_scale=22 =
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llspacing=3D=220=22 width=3D=22600=22>
                              <tbody>
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=22></td>
                                    <td width=3D=22540=22>
                                    <table align=3D=22left=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22=
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22margin: 0;  font-size:13px ; color:=23677b82; fo=
nt-family: 'PT Sans', Helvetica, Arial, sans-serif; line-height: 23px;mso-l=
ine-height-rule: exactly;=22><span> <b>Overview:</b> Computer Systems Valid=
ation (CSV) also known as Software Validation is all-pervasive in the Life =
Sciences Industry=2E It is a requirement of all the predicate rules, as wel=
l as 21 CFR 11 and Annex 11=2E However, unless one knows how to implement C=
SV, it is often very hard to detect the requirement for CSV, and very hard =
to determine what needs to be done, to meet domestic and / or international=
 regulations or business continuity requirements=2E In addition, the FDA ha=
s stepped up 21 CFR 11 inspections that include CSV=2E <a href=3D=22http://=
seminar=2Eglobalcompliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQG=
jL0WgBzfua2j8CBW6l5SshXe4B9plc8GjHsRSne1neCzg8h91VXtpKX%3DUWYCT&amp;_ei_=3D=
Eq2tf9zs59idfPO1Sc_9BblkK0fQqwyLwsfc0q1LAjQAF4r6-eBC4L2V6oes36-lOz22Nu68a-N=
kTaRJePpb9bk=2E=22 style=3D=22color: =23ED5B34; text-decoration: none;=22 t=
arget=3D=22_blank=22> Read more=2E=2E</a>=2E </span></td>
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gin: 0; font-size:14px ; color:=23677b82; font-family: 'PT Sans', Helvetica=
, Arial, sans-serif; line-height: 0;=22><span> <img alt=3D=22divider image=
=22 border=3D=220=22 class=3D=22divider=22 height=3D=228=22 src=3D=22http:/=
/www=2Eglobalcompliancepanel=2Ecom/images/email-img/divider-image=2Epng=22 =
style=3D=22display: inline-block;=22 width=3D=22113=22 /> </span></td>
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ding=3D=220=22 cellspacing=3D=220=22 class=3D=22table_scale=22 width=3D=226=
00=22>
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llspacing=3D=220=22 width=3D=22600=22>
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=22></td>
                                    <td valign=3D=22top=22 width=3D=22540=
=22><=21-- START OF LEFT COLUMN-->
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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22=
 width=3D=22230=22><=21-- START OF HEADING-->
                                       <tbody>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:24px; line-height:34px; mso-line-height-rule: exactly;=22>=
<span> Date & Time </span></td>
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                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 23px;mso-line-height-rule: exactly;=22><span> <strong>Date:</stron=
g> May 7th & 8th, 2018<br />
                                             <strong>Time:</strong> 9:00 AM=
 to 6:00 PM</span></td>
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or=3D=22=23ffffff=22 style=3D=22padding-top: 20px;=22 valign=3D=22top=22>
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=22 bgcolor=3D=22=23f5f6f6=22 style=3D=22border-left: 5px solid =23ED5B34; =
padding: 7px 20px;font-size: 13px; line-height: 18px; font-family: 'PT Sans=
', Helvetica, Arial, sans-serif; color:=23677b82; margin: 0 =21important; =
=22 valign=3D=22middle=22><a href=3D=22http://seminar=2Eglobalcompliancepan=
el=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGjL0WgBzfua2j8CBW6l5SshXe4B9pl=
c8GjHsRSne1neCzg8h91VXtpKX%3DUWART&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9BblkK0fQq=
wyLwsfc0q1LAjQAF4r6-eBC4L2V6oes36-lOz22Nu68a-NkTaRJePpb9bk=2E=22 style=3D=
=22 font-style: normal; color:=23677b82;=22 target=3D=22_blank=22>Download =
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T OF SPACER-->

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0=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=
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=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:24px; line-height:34px; mso-line-height-rule: exactly;=22>=
<span> Venue</span></td>
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                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 23px;mso-line-height-rule: exactly;=22><span> Zurich, Switzerland<=
br />
                                             Hilton Zurich Airport</span></=
td>
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padding: 7px 20px;font-size: 13px; line-height: 18px; font-family: 'PT Sans=
', Helvetica, Arial, sans-serif; color:=23677b82; margin: 0 =21important; =
=22 valign=3D=22middle=22><a href=3D=22http://seminar=2Eglobalcompliancepan=
el=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGjL0WgBzfua2j8CBW6l5SshXe4B9pl=
c8GjHsRSne1neCzg8h91VXtpKX%3DUWATT&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9BblkK0fQq=
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/www=2Eglobalcompliancepanel=2Ecom/images/email-img/divider-image=2Epng=22 =
style=3D=22display: inline-block;=22 width=3D=22113=22 /> </span></td>
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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
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=3D=22center=22 style=3D=22margin: 0; font-size:13px ; color:=23677b82; fon=
t-family: 'PT Sans', Helvetica, Arial, sans-serif; line-height: 23px;=22><s=
pan> <a href=3D=22http://seminar=2Eglobalcompliancepanel=2Ecom/pub/cc?_ri_=
=3DX0Gzc2X%3DYQpglLjHJlTQGjL0WgBzfua2j8CBW6l5SshXe4B9plc8GjHsRSne1neCzg8h91=
VXtpKX%3DUWYAT&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9BblkK0fQqwyLwsfc0q1LAjQAF4r6-=
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> <img alt=3D=22img-160-160=22 border=3D=220=22 height=3D=22120=22 src=3D=
=22http://www=2Eglobalcompliancepanel=2Ecom/images/seminars/angela_bazigos=
=2Ejpg=22 style=3D=22display: inline-block;=22 width=3D=2290=22 /> </a> </s=
pan></td>
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T OF SPACER-->

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=22100%=22></td>
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                                    <=21-- END OF SPACER--><=21-- START OF =
RIGHT COLUMN-->

                                    <table align=3D=22right=22 border=3D=22=
0=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=
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=22 width=3D=22420=22><=21-- START OF HEADING-->
                                       <tbody>
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:22px; line-height:24px; mso-line-height-rule: exactly;=22>=
<span> Angela Bazigos </span><br />
                                             <span style=3D=22 color:=23ED5=
B34; font-size:11px;=22><b>CEO, Touchstone Technologies Silicon Valley</b><=
/span><br />
                                             <span style=3D=22 color:=23ED5=
B34; font-size:11px;=22></span></td>
                                          </tr>
                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 20px;mso-line-height-rule: exactly;=22><span> <strong>Angela Bazig=
os, </strong>is the CEO of Touchstone Technologies Inc=2E She has 40 years =
of experience in the Life Sciences & Healthcare Industries=2E Experience co=
mbines Quality Assurance, Regulatory Compliance, Information Technology, Pr=
oject Management, Clinical Lab Science, Microbiology, Food Safety and Turna=
rounds=2E</span></td>
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                                          <=21-- END OF TEXT-->
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ont-size:14px ; color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, =
sans-serif; line-height: 0;=22><span> <img alt=3D=22top teaser=22 border=3D=
=220=22 class=3D=22img_scale=22 height=3D=2225=22 src=3D=22http://www=2Eglo=
balcompliancepanel=2Ecom/images/email-img/top-teaser=2Epng=22 style=3D=22di=
splay: block;=22 width=3D=22620=22 /> </span></td>
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=22></td>
                                    <td width=3D=22540=22><=21-- START OF L=
EFT COLUMN-->
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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
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line-height-rule: exactly;=22><span> Reserve your Seat Now </span></td>
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                                          <=21-- END OF HEADING-->
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                                    <=21-- END OF LEFT COLUMN--><=21-- STAR=
T OF SPACER-->

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olor=3D=22=23505050=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=
=3D=220=22 style=3D=22margin: 0;=22>
                                                <tbody>
                                                   <tr>
                                                      <td align=3D=22center=
=22 bgcolor=3D=22=23ED5B34=22 style=3D=22padding: 10px 30px;font-size: 16px=
; line-height: 18px; font-family: 'PT Sans', Helvetica, Arial, sans-serif; =
color:=23ffffff; margin: 0 =21important; =22 valign=3D=22middle=22><a href=
=3D=22http://seminar=2Eglobalcompliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3D=
YQpglLjHJlTQGjL0WgBzfua2j8CBW6l5SshXe4B9plc8GjHsRSne1neCzg8h91VXtpKX%3DUWYA=
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ormal; color:=23ffffff;=22 target=3D=22_blank=22>Enroll Now=21</a></td>
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                                          <=21-- END BUTTON-->
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ont-size:14px ; color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, =
sans-serif; line-height: 0;=22><span> <img alt=3D=22bottom teaser=22 border=
=3D=220=22 class=3D=22img_scale=22 height=3D=2225=22 src=3D=22http://www=2E=
globalcompliancepanel=2Ecom/images/email-img/bottom-teaser=2Epng=22 style=
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der=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22table_=
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<=21-- END OF CALL TO ACTION BLOCK--><=21-- START OF SUB-FOOTER BLOCK-->

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padding=3D=220=22 cellspacing=3D=220=22 width=3D=22100%=22>
   <tbody>
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         <table align=3D=22center=22 border=3D=220=22 cellpadding=3D=220=22=
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            <tbody>
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                  <td width=3D=22100%=22>
                  <table bgcolor=3D=22=23ffffff=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22table_scale=22 style=3D=22=
=22 width=3D=22600=22>
                     <tbody>
                        <tr>
                           <td width=3D=22100%=22>
                           <table border=3D=220=22 cellpadding=3D=220=22 ce=
llspacing=3D=220=22 width=3D=22600=22>
                              <tbody>
                                 <tr>
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=22></td>
                                    <td width=3D=22540=22><=21-- START OF L=
EFT COLUMN-->
                                    <table align=3D=22left=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22=
 width=3D=22540=22>
                                       <tbody>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22 width=3D=22540=22><strong>GlobalComp=
liancePanel </strong></td>
                                          </tr>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><span>161 Mission Falls Lane, Suite =
216, Fremont, CA 94539, USA=2E </span></td>
                                          </tr>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><strong>Phone:</strong> +1-800-447-9=
407</td>
                                          </tr>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><strong>Fax: </strong> 302 288 6884<=
/td>
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><a href=3D=22http://seminar=2Eglobal=
compliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGjL0WgBzfua2j8CBW=
6l5SshXe4B9plc8GjHsRSne1neCzg8h91VXtpKX%3DUWWAT&amp;_ei_=3DEq2tf9zs59idfPO1=
Sc_9BblkK0fQqwyLwsfc0q1LAjQAF4r6-eBC4L2V6oes36-lOz22Nu68a-NkTaRJePpb9bk=2E=
=22 style=3D=22font-weight: normal; font-style: normal; color:=23677b82; te=
xt-decoration: underline;=22 target=3D=22_blank=22>www=2Eglobalcompliancepa=
nel=2Ecom</a>&nbsp;=7C&nbsp;<a href=3D=22http://seminar=2Eglobalcompliancep=
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e4B9plc8GjHsRSne1neCzg8h91&amp;_ei_=3DEolaGGF4SNMvxFF7KucKuWOvyT2skr4dcz7Zr=
PSX_SNmjJPfAeD6K_LEz-g7ikgS0QitAQA1FXpD=22 style=3D=22font-weight: normal; =
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