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 Content preview:  Elements of CAPA Program and Uses of CAPA Data Friday, May
    11 2018 | 1:00 PM EST | 60 Minutes Course Summary [...] 
 
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                             [URIs: grceducators.com]
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                           <table align=3D=22center=22 bgcolor=3D=22=23ffff=
ff=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=
=22rnb-container=22 style=3D=22background-color:=23ffffff;=22 width=3D=2210=
0%=22>
                              <tbody>
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                                    <td align=3D=22center=22 valign=3D=22to=
p=22>
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=220=22 cellspacing=3D=220=22>
                                       <tbody>
                                          <tr>
                                             <td>
                                             <div style=3D=22display:block;=
 border-radius:0px; width:590;max-width:600px =21important;border-top:0px N=
one =23000;border-right:0px None =23000;border-bottom:0px None =23000;borde=
r-left:0px None =23000;border-collapse: separate;border-radius: 0px;=22>
                                             <div><a href=3D=22https://news=
=2Egrceducators=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGi4h4bMqp2dbzczcK=
zd0KzcTohzd8jJMmCeAhhvADhzbSm0b2HMzaGVXtpKX%3DUSYCT&amp;_ei_=3DEq2tf9zs59id=
fPO1Sc_9BbmtLGFdoihnNpnISoMHnn0iHJTST_D5cfr1BaPckz9_4DlATBVrsbwKJc1VzAyuhjc=
=2E=22 style=3D=22text-decoration:none;=22 target=3D=22_blank=22><img alt=
=3D=22=22 border=3D=220=22 class=3D=22rnb-header-img=22 hspace=3D=220=22 sr=
c=3D=22http://img=2Emailinblue=2Ecom/1620427/images/rnb/original/5ad862dde6=
94aa151935d48c=2Epng=22 style=3D=22display:block; float:left; border-radius=
: 0px; =22 vspace=3D=220=22 width=3D=22590=22 /> </a>
                                             </div>

                                             <div style=3D=22clear:both;=22>
                                             </div>
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                  <=21--=5Bif mso=5D>
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=3D=22background-color:=23f9fafc;=22 valign=3D=22top=22>
                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
g=3D=220=22 width=3D=22100%=22 style=3D=22width:100%;=22>
<tr>
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                  <table bgcolor=3D=22=23f9fafc=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 id=3D=22Layout_6=22 name=3D=22Layout_6=
=22 style=3D=22background-color:=23f9fafc;=22 width=3D=22100%=22>
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=22 style=3D=22background-color: =23f9fafc;=22 valign=3D=22top=22>
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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-container=22=
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s: 0px; border-collapse: separate; padding-left: 20px; padding-right: 20px;=
=22 width=3D=22100%=22>
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=22rnb-container-padding=22 style=3D=22background-color: =23ffffff; font-si=
ze: px;font-family: ; color: ;=22>
                                    <table align=3D=22center=22 border=3D=
=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-columns-=
container=22 style=3D=22margin:auto;=22>
                                       <tbody>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22rnb-force-col=22>
                                             <table align=3D=22center=22 bo=
rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-c=
ol-1=22>
                                                <tbody>
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                                                      <td height=3D=2210=22=
></td>
                                                   </tr>
                                                   <tr>
                                                      <td style=3D=22font-f=
amily:Arial,Helvetica,sans-serif; color:=233c4858; text-align:center;=22><s=
pan style=3D=22color:=233c4858;=22><span style=3D=22font-size:18px;=22><str=
ong>Friday, May 11 2018 =7C 1:00 PM EST =7C 60 Minutes</strong></span></spa=
n></td>
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></td>
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                  <=21--=5Bif mso=5D>
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               <tr>
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=3D=22background-color:=23f9fafc;=22 valign=3D=22top=22>
                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
g=3D=220=22 width=3D=22100%=22 style=3D=22width:100%;=22>
<tr>
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<td valign=3D=22top=22 width=3D=22590=22 style=3D=22width:590px;=22>
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                  <table bgcolor=3D=22=23f9fafc=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 id=3D=22Layout_8=22 name=3D=22Layout_8=
=22 style=3D=22background-color:=23f9fafc;=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
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=22 style=3D=22background-color: =23f9fafc;=22 valign=3D=22top=22>
                           <table bgcolor=3D=22=23ffffff=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-container=22=
 style=3D=22height: 0px; background-color: rgb(255, 255, 255); border-radiu=
s: 0px; border-collapse: separate; padding-left: 20px; padding-right: 20px;=
=22 width=3D=22100%=22>
                              <tbody>
                                 <tr>
                                    <td bgcolor=3D=22=23ffffff=22 class=3D=
=22rnb-container-padding=22 style=3D=22background-color: =23ffffff; font-si=
ze: px;font-family: ; color: ;=22>
                                    <table align=3D=22left=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-columns-cont=
ainer=22 style=3D=22margin:auto;=22>
                                       <tbody>
                                          <tr>
                                             <td align=3D=22left=22 class=
=3D=22rnb-force-col=22>
                                             <table align=3D=22center=22 bo=
rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-c=
ol-1=22>
                                                <tbody>
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                                                      <td height=3D=2210=22=
></td>
                                                   </tr>
                                                   <tr>
                                                      <td style=3D=22font-f=
amily:Arial,Helvetica,sans-serif; color:=233c4858; text-align:left;=22><spa=
n style=3D=22color:=233c4858;=22><span style=3D=22font-size:18px;=22><stron=
g>Course Summary</strong></span></span></td>
                                                   </tr>
                                                   <tr>
                                                      <td height=3D=2210=22=
></td>
                                                   </tr>
                                                </tbody>
                                             </table>
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                  <=21--=5Bif mso=5D>
</td>
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<=21=5Bendif=5D-->
                  </div>
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               <tr>
                  <td align=3D=22center=22 bgcolor=3D=22=23f9fafc=22 style=
=3D=22background-color:=23f9fafc;=22 valign=3D=22top=22>
                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
g=3D=220=22 width=3D=22100%=22 style=3D=22width:100%;=22>
<tr>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
<td valign=3D=22top=22 width=3D=22590=22 style=3D=22width:590px;=22>
<=21=5Bendif=5D-->
                  <table bgcolor=3D=22=23f9fafc=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-del-min-width=22 name=
=3D=22Layout_9=22 style=3D=22min-width:100%; background-color:=23f9fafc;=22=
 width=3D=22100%=22>
                     <tbody>
                        <tr>
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=22 class=3D=22rnb-del-min-width=22 style=3D=22background-color: =23f9fafc;=
=22 valign=3D=22top=22>
                           <table bgcolor=3D=22=23ffffff=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-container=22=
 style=3D=22background-color: rgb(255, 255, 255); padding-left: 20px; paddi=
ng-right: 20px; border-collapse: separate; border-radius: 0px; border-botto=
m: 0px none rgb(200, 200, 200);=22 width=3D=22100%=22>
                              <tbody>
                                 <tr>
                                    <td height=3D=220=22 style=3D=22font-si=
ze:1px; line-height:1px;=22></td>
                                 </tr>
                                 <tr>
                                    <td align=3D=22left=22 bgcolor=3D=22=23=
ffffff=22 class=3D=22rnb-container-padding=22 style=3D=22background-color: =
=23ffffff;=22 valign=3D=22top=22>
                                    <table border=3D=220=22 cellpadding=3D=
=220=22 cellspacing=3D=220=22 class=3D=22rnb-columns-container=22 width=3D=
=22100%=22>
                                       <tbody>
                                          <tr>
                                             <td class=3D=22rnb-force-col=
=22 style=3D=22padding-right: 0px;=22 valign=3D=22top=22>
                                             <table align=3D=22left=22 bord=
er=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-col=
-1=22 valign=3D=22top=22 width=3D=22100%=22>
                                                <tbody>
                                                   <tr>
                                                      <td style=3D=22font-s=
ize:14px; font-family:Arial,Helvetica,sans-serif, sans-serif; color:=233c48=
58; line-height: 21px;=22>
                                                      <div>
                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22>Y=
ear after year, CAPA is the subsystem cited most frequently during FDA insp=
ections=2E A robust Corrective and Preventive Action (CAPA) program is of t=
he utmost importance to a medical device manufacturer=2E A system that iden=
tifies and eliminates nonconformances and potential nonconformances enables=
 both regulatory compliance and cost savings=2E This session will discuss t=
he importance, requirements, and elements of a CAPA program, as well as des=
cribing the uses of CAPA data=2E Additionally, the application of risk mana=
gement to a CAPA program will be reviewed, and a specific risk management s=
ystem detailed=2E</span>
                                                      </div>

                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22>
                                                      </div>
                                                      &nbsp;

                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22>T=
his session will cover all the items listed above, and more=2E If you want =
to improve your CAPA system, you cannot afford to miss this=2E</span>
                                                      </div>

                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22><br />
                                                      <span style=3D=22font=
-size:16px;=22><strong>Learning Objective</strong></span>
                                                      </div>

                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22>
                                                      </div>

                                                      <ul>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Applicable Regulations</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Contents of Procedure(s)</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Detection of nonconformance</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Identification of cause (Investigation)</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Review of Investigation</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Determination of Corrective/Preventive Action</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Performance of Corrective/Preventive Action</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Implementation of Corrective/Preventive Action</span></li>
                                                         <li style=3D=22lin=
e-height: 16px; text-align: justify;=22><span style=3D=22font-size:12px;=22=
>Effectiveness of Corrective Action</span></li>
                                                      </ul>

                                                      <div style=3D=22line-=
height: 16px; text-align: justify;=22>
                                                      </div>
                                                      </div>
                                                      </td>
                                                   </tr>
                                                </tbody>
                                             </table>
                                             </td>
                                          </tr>
                                       </tbody>
                                    </table>
                                    </td>
                                 </tr>
                                 <tr>
                                    <td height=3D=220=22 style=3D=22font-si=
ze:1px; line-height:1px;border-bottom:0px;=22></td>
                                 </tr>
                              </tbody>
                           </table>
                           </td>
                        </tr>
                     </tbody>
                  </table>
                  <=21--=5Bif mso=5D>
</td>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
</tr>
</table>
<=21=5Bendif=5D-->
                  </div>
                  </td>
               </tr>
               <tr>
                  <td align=3D=22center=22 bgcolor=3D=22=23f9fafc=22 style=
=3D=22background-color:=23f9fafc;=22 valign=3D=22top=22>
                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
g=3D=220=22 width=3D=22100%=22 style=3D=22width:100%;=22>
<tr>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
<td valign=3D=22top=22 width=3D=22590=22 style=3D=22width:590px;=22>
<=21=5Bendif=5D-->
                  <table bgcolor=3D=22=23f9fafc=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-del-min-width=22 id=3D=
=22Layout_10=22 name=3D=22Layout_10=22 style=3D=22min-width:590px; backgrou=
nd-color:=23f9fafc;=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
                           <td align=3D=22center=22 bgcolor=3D=22=23f9fafc=
=22 class=3D=22rnb-del-min-width=22 style=3D=22min-width:590px; background-=
color: =23f9fafc;=22 valign=3D=22top=22>
                           <table bgcolor=3D=22=23ffffff=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22mso-button-block=
 rnb-container=22 style=3D=22background-color: rgb(255, 255, 255); border-r=
adius: 0px; padding-left: 20px; padding-right: 20px; border-collapse: separ=
ate;=22 width=3D=22100%=22>
                              <tbody>
                                 <tr>
                                    <td height=3D=2220=22 style=3D=22font-s=
ize:1px; line-height:1px;=22></td>
                                 </tr>
                                 <tr>
                                    <td align=3D=22left=22 bgcolor=3D=22=23=
ffffff=22 class=3D=22rnb-container-padding=22 style=3D=22background-color: =
=23ffffff;=22 valign=3D=22top=22>
                                    <table border=3D=220=22 cellpadding=3D=
=220=22 cellspacing=3D=220=22 class=3D=22rnb-columns-container=22 width=3D=
=22100%=22>
                                       <tbody>
                                          <tr>
                                             <td class=3D=22rnb-force-col=
=22 valign=3D=22top=22>
                                             <table align=3D=22center=22 bo=
rder=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-c=
ol-1=22 valign=3D=22top=22 width=3D=22550=22>
                                                <tbody>
                                                   <tr>
                                                      <td valign=3D=22top=
=22>
                                                      <table align=3D=22cen=
ter=22 border=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=
=3D=22rnb-btn-col-content=22 style=3D=22margin:auto; border-collapse: separ=
ate;=22>
                                                         <tbody>
                                                            <tr>
                                                               <td align=3D=
=22center=22 bgcolor=3D=22=23ff000f=22 height=3D=2227=22 style=3D=22font-si=
ze:18px; font-family:Arial,Helvetica,sans-serif; color:=23ffffff; font-weig=
ht:normal; padding-left:20px; padding-right:20px; vertical-align: middle; b=
ackground-color:=23ff000f;border-radius:0px;border-top:0px None =23000;bord=
er-right:0px None =23000;border-bottom:0px None =23000;border-left:0px None=
 =23000;=22 valign=3D=22middle=22 width=3D=22auto=22><span style=3D=22color=
:=23ffffff; font-weight:normal;=22> <a href=3D=22https://news=2Egrceducator=
s=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGi4h4bMqp2dbzczcKzd0KzcTohzd8jJ=
MmCeAhhvADhzbSm0b2HMzaGVXtpKX%3DUSYCT&amp;_ei_=3DEq2tf9zs59idfPO1Sc_9BbmtLG=
FdoihnNpnISoMHnn0iHJTST_D5cfr1BaPckz9_4DlATBVrsbwKJc1VzAyuhjc=2E=22 style=
=3D=22text-decoration:none; color:=23ffffff; font-weight:normal;=22 target=
=3D=22_blank=22> Register Now </a> </span></td>
                                                            </tr>
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                                                </tbody>
                                             </table>
                                             </td>
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                                 <tr>
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ize:1px; line-height:1px;=22></td>
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                        </tr>
                     </tbody>
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                  <=21--=5Bif mso=5D>
</td>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
</tr>
</table>
<=21=5Bendif=5D-->
                  </div>
                  </td>
               </tr>
               <tr>
                  <td align=3D=22center=22 bgcolor=3D=22=23f9fafc=22 style=
=3D=22background-color:=23f9fafc;=22 valign=3D=22top=22>
                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
g=3D=220=22 width=3D=22100%=22 style=3D=22width:100%;=22>
<tr>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
<td valign=3D=22top=22 width=3D=22590=22 style=3D=22width:590px;=22>
<=21=5Bendif=5D-->
                  <table bgcolor=3D=22=23f9fafc=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-del-min-width=22 id=3D=
=22Layout_=22 name=3D=22Layout_=22 style=3D=22min-width:100%; background-co=
lor:=23f9fafc;=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
                           <td align=3D=22center=22 bgcolor=3D=22=23f9fafc=
=22 class=3D=22rnb-del-min-width=22 style=3D=22background-color: =23f9fafc;=
=22 valign=3D=22top=22>
                           <table bgcolor=3D=22=23f2f2f2=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-container=22=
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