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Subject: How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
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 Content preview:  View Online Live Webinar How FDA Trains its Investigators
    to Review CAPA and What you Should do to Prepare REGISTER NOW! Also contained
    in this session will be a section-by-section summary of the CAPA subsection
    of the QSIT, the document by which FDA inspectors operate during an inspection,
    as well as how your company can use that same document to increase the likelihood
    of a positive outcome during the inspection. Date: Friday, April 13, 2018
    Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: Jeff Kasoff
    Overview: Year after year, CAPA is the subsystem cited most frequently during
    FDA inspections. During an inspection, FDA personnel will take a great deal
    of time reviewing your company's CAPA system. What will they look for? This
    session will discuss techniques used by the FDA to review your CAPA system.
    The documents used by FDA to train their inspectors to review your CAPA system
    will be explained, some of which you may not be familiar with. Read more...
    Who Will Benefit: QA Management CAPA Coordinator Regulatory Affairs Management
    Executive Management Consultants Quality System Auditors About Speaker: Jeff
    Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, CMQ/OE
    is the Principal Consultant at Lean to Quality, LLC. He s has more than 30
    years of experience in Quality and Regulatory management. Over that time,
    Jeff has implemented and overseen quality system operations and assured compliance,
    at all sizes of company, from start-up to more than $100 million in revenue...
    Read More Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539,
    USA. Toll Free: +1-800-447-9407 Fax: 302 288 6884 www.compliance4all.com
   | Unsubscribe Copyright © 2017 compliance4All. All rights reserved. [...]
    
 
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eight: 1=2E15; font-size: 18px; font-weight: bold; padding-top:20px; color:=
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u Should do to Prepare</a></td>
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g-top:30px; padding-bottom:25px;=22>
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=22 mc:edit=3D=22m04=22 style=3D=22color:=2358585A; font-family: 'Lato',Ari=
al,sans-serif; font-size: 14px; font-weight: 400; line-height: 20px; text-a=
lign:center;=22>Also contained in this session will be a section-by-section=
 summary of the CAPA subsection of the QSIT, the document by which FDA insp=
ectors operate during an inspection, as well as how your company can use th=
at same document to increase the likelihood of a positive outcome during th=
e inspection=2E</td>
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F9; border-left: 1px solid =23C0C0C0; border-right: 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=22600=22>
                                       <tbody>
                                          <tr>
                                             <td align=3D=22center=22 style=
=3D=22padding:5px 5px 25px 5px;=22>
                                             <table align=3D=22center=22 bo=
rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22conta=
iner=22 style=3D=22margin: 0 auto;=22 width=3D=22560=22>
                                                <tbody>
                                                   <tr>
                                                      <td class=3D=22h2=22 =
mc:edit=3D=22m09=22 style=3D=22font-family: 'Lato',Arial,sans-serif; line-h=
eight: 24px; font-size: 16px; font-weight: normal; padding-top:20px; color:=
 =23464646; text-align:Center;=22><strong>Date: Friday, April 13, 2018</str=
ong><br />
                                                      Time: 10:00 AM PDT =
=7C 01:00 PM EDT<br />
                                                      Duration: 60 Minutes<=
br />
                                                      Instructor: Jeff Kaso=
ff</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: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>Year after year, CAPA is the subsystem cited=
 most frequently during FDA inspections=2E During an inspection, FDA person=
nel will take a great deal of time reviewing your company's CAPA system=2E =
What will they look for? This session will discuss techniques used by the F=
DA to review your CAPA system=2E The documents used by FDA to train their i=
nspectors to review your CAPA system will be explained, some of which you m=
ay not be familiar with=2E <a href=3D=22http://webcast=2Ecompliance4all=2Ec=
om/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGm5s6UIXzcEY5zcozfzflSLJsRXAr0euzdKA=
zfYXTecsCBzbMwpAMqzgS5zgcMKMzdSnVXtpKX%3DSYRCT&amp;_ei_=3DEq2tf9zs59idfPO1S=
c_9BbkwfoXCIqZCBXO7T8HvbxNIGHhqcCHjuN309Y6V8OK_2Y59YHIwfrOJhL1JlXdQcLxfYw=
=2E=22 style=3D=22color: =230099D4; text-decoration: none;=22 target=3D=22_=
blank=22> Read more=2E=2E</a>=2E</td>
                                                   </tr>
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button) --><=21-- Layout 12 (Image - left, text - right) -->

                           <table align=3D=22center=22 border=3D=220=22 cel=
lpadding=3D=220=22 cellspacing=3D=220=22 mc:repeatable=3D=22=22 width=3D=22=
100%=22>
                              <tbody>
                                 <tr>
                                    <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>
                                          <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>
                                                   <tr>
                                                      <td class=3D=22spacer=
=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>QA Ma=
nagement</li>
                                                                  <li>CAPA =
Coordinator</li>
                                                                  <li>Regul=
atory Affairs Management</li>
                                                                  <li>Execu=
tive Management</li>
                                                                  <li>Consu=
ltants</li>
                                                                  <li>Quali=
ty System Auditors</li>
                                                               </ul>
                                                               </td>
                                                            </tr>
                                                         </tbody>
                                                      </table>
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ent --><=21-- spacer -->

                                                      <table align=3D=22lef=
t=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 width=3D=
=225=22>
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                                                               <td class=3D=
=22spacer=22 height=3D=2220=22 style=3D=22font-size: 0; line-height: 0;=22>=
</td>
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                                                      <=21-- end spacer -->=
<=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 />
                                                               Jeff Kasoff<=
/span><br />
                                                               Director of =
Regulatory Affairs, Life-Tech, Inc<br />
                                                               <strong>Jeff=
 Kasoff</strong>, RAC, CMQ/OE is the Principal Consultant at Lean to Qualit=
y, LLC=2E He s has more than 30 years of experience in Quality and Regulato=
ry management=2E Over that time, Jeff has implemented and overseen quality =
system operations and assured compliance, at all sizes of company, from sta=
rt-up to more than =24100 million in revenue=2E=2E=2E <a href=3D=22http://w=
ebcast=2Ecompliance4all=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGm5s6UIXz=
cEY5zcozfzflSLJsRXAr0euzdKAzfYXTecsCBzbMwpAMqzgS5zgcMKMzdSnVXtpKX%3DSRSTT&a=
mp;_ei_=3DEq2tf9zs59idfPO1Sc_9BbkwfoXCIqZCBXO7T8HvbxNIGHhqcCHjuN309Y6V8OK_2=
Y59YHIwfrOJhL1JlXdQcLxfYw=2E=22 style=3D=22color:=230099D4; text-decoration=
:underline;=22 target=3D=22_blank=22>Read More</a></td>
                                                            </tr>
                                                         </tbody>
                                                      </table>
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nt --></td>
                                                   </tr>
                                                   <tr>
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=22 height=3D=2230=22 style=3D=22font-size: 0; line-height: 0;=22></td>
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                                    </td>
                                 </tr>
                              </tbody>
                           </table>
                           <=21-- End Layout 12 (Image - left, text - right=
) --><=21-- Layout 22 (Gallery) -->

                           <table align=3D=22center=22 border=3D=220=22 cel=
lpadding=3D=220=22 cellspacing=3D=220=22 mc:repeatable=3D=22=22 width=3D=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>
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                                             <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>
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                                                      <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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ign: center;=22>Fax: 302 288 6884<br />
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