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Subject: FDA's New Enforcement of 21 CFR Part 11
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 Content preview:  View Online Live Webinar FDA's New Enforcement of 21 CFR
   Part 11 REGISTER NOW! The webinar will have the answers. In addition, using
    industry proven case studies on how to avoid 483 inspectional observations
    and warning letters attendees will learn how to prepare their organization
    for trouble-free Part 11 related inspections. Date: Monday, April 30, 2018
    Time: 10:00 AM PDT | 01:00 PM EDT Duration: 75 Minutes Instructor: Dr. Ludwig
    Huber Overview: [...] 
 
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g-top:30px; padding-bottom:25px;=22>
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al,sans-serif; font-size: 14px; font-weight: 400; line-height: 20px; text-a=
lign:center;=22>The webinar will have the answers=2E In addition, using ind=
ustry proven case studies on how to avoid 483 inspectional observations and=
 warning letters attendees will learn how to prepare their organization for=
 trouble-free Part 11 related inspections=2E</td>
                                                   </tr>
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eight: 24px; font-size: 16px; font-weight: normal; padding-top:20px; color:=
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                                                      Time: 10:00 AM PDT =
=7C 01:00 PM EDT<br />
                                                      Duration: 75 Minutes<=
br />
                                                      Instructor: Dr=2E Lud=
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                                                   <tr>
                                                      <td class=3D=22text=
=22 mc:edit=3D=22m04=22 style=3D=22color:=2358585A; font-family: 'Lato',Ari=
al,sans-serif; padding-top:20px; font-size: 15px; font-weight: 600; line-he=
ight: 20px; text-align:left;=22><strong>Overview:</strong></td>
                                                   </tr>
                                                   <tr>
                                                      <td class=3D=22text=
=22 mc:edit=3D=22m04=22 style=3D=22color:=2358585A; font-family: 'Lato',Ari=
al,sans-serif; padding-top:5px; font-size: 14px; font-weight: 400; line-hei=
ght: 20px; text-align:left;=22>
                                                      <p>FDA continues to e=
nforce Part 11 through its new Part 11 inspection and enforcement program=
=2E Just in the last 3 years, FDA issued more than 30 warning letters with =
Part 11 violations=2E Citations are related to inadequate integrity, securi=
ty and availability of electronic records but also related to validation of=
 software and computer systems=2E There are many questions about the progra=
m, e=2Eg=2E, what inspectors are looking at what are major findings=2E <a h=
ref=3D=22http://webcast=2Ecompliance4all=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpg=
lLjHJlTQGoDHkvuw1G4zfj5zg4kP7zggRAzgzb8HEGkTIze9bPEBuzbSoXajzedjVXtpKX%3DTW=
DTT&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9Bbm_e1dn-yCJFSOZnmQsAXrZeYpNoHt2uJalBVl9=
nvjvYh8sv8egVMLnS5_RoPIhtveLWU8=2E=22 style=3D=22color: =230099D4; text-dec=
oration: none;=22 target=3D=22_blank=22> Read more=2E=2E</a>=2E
                                                      </p>
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button) --><=21-- Layout 12 (Image - left, text - right) -->

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lpadding=3D=220=22 cellspacing=3D=220=22 mc:repeatable=3D=22=22 width=3D=22=
100%=22>
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                                    <td bgcolor=3D=22=23FFFFFF=22 style=3D=
=22background-color:=23FFFFFF; border-left: 1px solid =23C0C0C0; border-rig=
ht: 1px solid =23C0C0C0;=22>
                                    <table align=3D=22center=22 border=3D=
=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22container=22=
 style=3D=22margin: 0 auto;=22 width=3D=22550=22>
                                       <tbody>
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rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 width=3D=22100%=
=22>
                                                <tbody>
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=22 height=3D=2230=22 style=3D=22font-size: 0; line-height: 0;=22></td>
                                                   </tr>
                                                   <tr>
                                                      <td><=21-- image cont=
ent -->
                                                      <table align=3D=22lef=
t=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=
=22m-w100=22 style=3D=22border-collapse: collapse; mso-table-lspace: 0pt; m=
so-table-rspace: 0pt;=22 width=3D=22260=22>
                                                         <tbody>
                                                            <tr>
                                                               <td class=3D=
=22text=22 mc:edit=3D=22m06=22 style=3D=22color: =23777777; font-family: 'L=
ato', Arial, sans-serif; font-size: 14px; font-weight: 400; line-height: 22=
px;=22><span style=3D=22font-size:15px; font-weight: bold;=22>Who Will Bene=
fit:</span>
                                                               <ul>
                                                                  <li>QC Ma=
nagers</li>
                                                                  <li>QA Ma=
nagers and Personnel</li>
                                                                  <li>IT Ad=
ministrators</li>
                                                                  <li>Analy=
sts</li>
                                                                  <li>Regul=
atory Affairs</li>
                                                                  <li>Train=
ing Departments</li>
                                                                  <li>Docum=
entation Department</li>
                                                                  <li>Consu=
ltants</li>
                                                               </ul>
                                                               </td>
                                                            </tr>
                                                         </tbody>
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ent --><=21-- spacer -->

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t=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 width=3D=
=225=22>
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=22spacer=22 height=3D=2220=22 style=3D=22font-size: 0; line-height: 0;=22>=
</td>
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<=21-- text content -->

                                                      <table align=3D=22rig=
ht=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=
=22m-w100=22 style=3D=22border-collapse: collapse; mso-table-lspace: 0pt; m=
so-table-rspace: 0pt;=22 width=3D=22260=22>
                                                         <tbody>
                                                            <tr>
                                                               <td class=3D=
=22text=22 mc:edit=3D=22m06=22 style=3D=22color: =23777777; font-family: 'L=
ato', Arial, sans-serif; font-size: 14px; font-weight: 400; line-height: 22=
px;=22><span style=3D=22font-size:15px; font-weight: bold;=22>About Speaker=
:<br />
                                                               Dr=2E Ludwig=
 Huber</span><br />
                                                               Director , L=
abcompliance<br />
                                                               <strong>Ludw=
ig Huber Ph=2ED=2E,</strong> is the director and editor of Labcompliance th=
e global online resource for validation and compliance=2E He is the author =
of the books =22Validation and Qualification in Analytical Laboratories=22 =
and =22Validation of Computerized Analytical and Networked Systems, Informa=
 Healthcare=22=2E=2E=2E <a href=3D=22http://webcast=2Ecompliance4all=2Ecom/=
pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGoDHkvuw1G4zfj5zg4kP7zggRAzgzb8HEGkTIze=
9bPEBuzbSoXajzedjVXtpKX%3DTWDWT&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9Bbm_e1dn-yCJ=
FSOZnmQsAXrZeYpNoHt2uJalBVl9nvjvYh8sv8egVMLnS5_RoPIhtveLWU8=2E=22 style=3D=
=22color:=230099D4; text-decoration:underline;=22 target=3D=22_blank=22>Rea=
d More</a></td>
                                                            </tr>
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nt --></td>
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=22 height=3D=2230=22 style=3D=22font-size: 0; line-height: 0;=22></td>
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) --><=21-- Layout 22 (Gallery) -->

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lpadding=3D=220=22 cellspacing=3D=220=22 mc:repeatable=3D=22=22 width=3D=22=
100%=22>
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9f9;border-left: 1px solid =23C0C0C0;  border-right: 1px solid =23C0C0C0;bo=
rder-bottom: 1px solid =23C0C0C0; =22>
                                    <table align=3D=22center=22 border=3D=
=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22container=22=
 style=3D=22margin: 0 auto; width: 550px;=22 width=3D=22560=22>
                                       <tbody>
                                          <tr>
                                             <td>
                                             <table align=3D=22center=22 bo=
rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 width=3D=22100%=
=22>
                                                <tbody>
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                                                      <td class=3D=22spacer=
=22 height=3D=2225=22 style=3D=22font-size: 1px; line-height: 25px;=22></td>
                                                   </tr>
                                                   <tr>
                                                      <td class=3D=22h2=22 =
mc:edit=3D=22m09=22 style=3D=22font-family: 'Lato',Arial,sans-serif; paddin=
g-bottom:10px; line-height: 1=2E15; font-size: 15px; color: =23464646; text=
-align: center;=22><strong>Compliance4All</strong></td>
                                                   </tr>
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                                                      <td class=3D=22h2=22 =
mc:edit=3D=22m09=22 style=3D=22font-family: 'Lato',Arial,sans-serif; line-h=
eight: 20px; font-size: 13px; color: =23464646; padding-bottom:5px; text-al=
ign: center;=22>161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA=
=2E</td>
                                                   </tr>
                                                   <tr>
                                                      <td class=3D=22h2=22 =
mc:edit=3D=22m09=22 style=3D=22font-family: 'Lato',Arial,sans-serif; line-h=
eight: 1=2E15; font-size:18px; color: =23464646; text-align: center;=22>Tol=
l Free: +1-800-447-9407</td>
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mc:edit=3D=22m09=22 style=3D=22font-family: 'Lato',Arial,sans-serif; line-h=
eight: 20px; font-size: 13px; color: =23464646; padding-bottom:5px; text-al=
ign: center;=22>Fax: 302 288 6884<br />
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