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Subject: Regulatory Agency Inspection-Assignments and Responsibilities for the Inspection
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 Content preview:  Regulatory Agency Inspection - Assignments and Responsibilities
    for the Inspection 740-870-0321 Proper Management of Regulatory Agency Inspections
    [...] 
 
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                                             <td class=3D=22rnb-force-col=
=22 valign=3D=22top=22>
                                             <table align=3D=22left=22 bord=
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                                                <tbody>
                                                   <tr>
                                                      <td style=3D=22font-s=
ize:24px; font-family:Arial,Helvetica,sans-serif; color:=233c4858; text-ali=
gn:right;=22><span style=3D=22color:=233c4858; =22><span style=3D=22color:=
=23000000;=22><strong><span style=3D=22font-size: 18px;=22>740-870-0321</sp=
an></strong></span></span></td>
                                                   </tr>
                                                   <tr>
                                                      <td height=3D=2210=22=
 style=3D=22font-size:1px; line-height:1px;=22></td>
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                                                   <tr>
                                                      <td class=3D=22rnb-mb=
l-float-none=22 style=3D=22font-size:14px; font-family:Arial,Helvetica,sans=
-serif;color:=233c4858;float:right;width:350px; line-height: 21px;=22></td>
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                                    <td height=3D=220=22 style=3D=22font-si=
ze:1px; line-height:1px;=22></td>
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                  <td align=3D=22center=22 bgcolor=3D=22=23ededed=22 style=
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                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
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<tr>
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=22Layout_22=22 name=3D=22Layout_22=22 style=3D=22min-width:100%; -webkit-b=
ackface-visibility: hidden; line-height: 10px; background-color:=23ededed;=
=22 width=3D=22100%=22>
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                           <td align=3D=22center=22 class=3D=22rnb-del-min-=
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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=
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                              <tbody>
                                 <tr>
                                    <td align=3D=22center=22 valign=3D=22to=
p=22>
                                    <table border=3D=220=22 cellpadding=3D=
=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 =239c9c9c;border-right:0px None =239c9c9c;border-bottom:0px None =239c9=
c9c;border-left:0px None =239c9c9c;border-collapse: separate;border-radius:=
 0px;=22>
                                             <div><a href=3D=22https://news=
=2Egrceducators=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGigCWNLOCGiHnpnzg=
MMYwshiLzbri58p6oDLUkitFrOeDryYnVXtpKX%3DTDDAT&amp;_ei_=3DEq2tf9zs59idfPO1S=
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=22=22 border=3D=220=22 class=3D=22rnb-header-img=22 hspace=3D=220=22 src=
=3D=22http://img=2Emailinblue=2Ecom/1620427/images/rnb/original/5acdda33bbd=
dbd543621ee3f=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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                  <td align=3D=22center=22 bgcolor=3D=22=23ededed=22 style=
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                  <div><=21--=5Bif mso=5D>
<table align=3D=22left=22 border=3D=220=22 cellspacing=3D=220=22 cellpaddin=
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<tr>
<=21=5Bendif=5D--><=21--=5Bif mso=5D>
<td valign=3D=22top=22 width=3D=22590=22 style=3D=22width:590px;=22>
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=22Layout_20=22 name=3D=22Layout_20=22 style=3D=22min-width:100%; -webkit-b=
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=22 width=3D=22100%=22>
                     <tbody>
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                           <td align=3D=22center=22 class=3D=22rnb-del-min-=
width=22 style=3D=22min-width: 590px;=22 valign=3D=22top=22>
                           <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>
                                 <tr>
                                    <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:5px; width:590;;max-width:600px =21important;border-top:0px =
None =23000;border-right:0px None =23000;border-bottom:0px None =23000;bord=
er-left:0px None =23000;border-collapse: separate;border-radius: 0px;=22>
                                             <div><img alt=3D=22=22 border=
=3D=220=22 class=3D=22rnb-header-img=22 hspace=3D=220=22 src=3D=22http://im=
g=2Emailinblue=2Ecom/1620427/images/rnb/original/5a719dfde694aa5fd728a9b2=
=2Epng=22 style=3D=22display:block; float:left; border-radius: 5px; =22 vsp=
ace=3D=220=22 width=3D=22590=22 />
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                                             <div style=3D=22clear:both;=22>
                                             </div>
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                                       </tbody>
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                                    </td>
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                  <=21--=5Bif mso=5D>
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<=21=5Bendif=5D--><=21--=5Bif mso=5D>
</tr>
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<=21=5Bendif=5D-->
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               <tr>
                  <td align=3D=22center=22 bgcolor=3D=22=23ededed=22 style=
=3D=22background-color:=23ededed;=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=23ededed=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 id=3D=22Layout_19=22 name=3D=22Layout_=
19=22 style=3D=22background-color:=23ededed;=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
                           <td align=3D=22center=22 bgcolor=3D=22=23ededed=
=22 style=3D=22background-color: =23ededed;=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=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>
                                                   <tr>
                                                      <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=22color:=23000000;=22><sp=
an style=3D=22font-size: 30px;=22><strong>Proper Management of Regulatory A=
gency Inspections</strong></span></span></span></td>
                                                   </tr>
                                                   <tr>
                                                      <td height=3D=2210=22=
></td>
                                                   </tr>
                                                </tbody>
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                                    </td>
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                              </tbody>
                           </table>
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                     </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=23ededed=22 style=
=3D=22background-color:=23ededed;=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=23ededed=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-del-min-width=22 name=
=3D=22Layout_12=22 style=3D=22min-width:100%; background-color:=23ededed;=
=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
                           <td align=3D=22center=22 bgcolor=3D=22=23ededed=
=22 class=3D=22rnb-del-min-width=22 style=3D=22background-color: =23ededed;=
=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>
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                                    <td height=3D=22=22 style=3D=22font-siz=
e: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:15px; font-family:'Arial',Helvetica,sans-serif, sans-serif; color:=2366=
6; line-height: 21px;=22>
                                                      <div>
                                                      <div style=3D=22text-=
align: center;=22><span style=3D=22color:=23000000;=22><span style=3D=22fon=
t-size: 17px;=22><strong>TUESDAY MAY 8 2018 =7C 01:00 PM EST =7C 60 MINUTES=
</strong></span></span>
                                                      </div>
                                                      </div>
                                                      </td>
                                                   </tr>
                                                </tbody>
                                             </table>
                                             </td>
                                          </tr>
                                       </tbody>
                                    </table>
                                    </td>
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                                 <tr>
                                    <td height=3D=2210=22 style=3D=22font-s=
ize:1px; line-height:1px;border-bottom:0px;=22></td>
                                 </tr>
                              </tbody>
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                           </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=23ededed=22 style=
=3D=22background-color:=23ededed;=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=23ededed=22 border=3D=220=22 cellpad=
ding=3D=220=22 cellspacing=3D=220=22 class=3D=22rnb-del-min-width=22 name=
=3D=22Layout_14=22 style=3D=22min-width:100%; background-color:=23ededed;=
=22 width=3D=22100%=22>
                     <tbody>
                        <tr>
                           <td align=3D=22center=22 bgcolor=3D=22=23ededed=
=22 class=3D=22rnb-del-min-width=22 style=3D=22background-color: =23ededed;=
=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 style=3D=22line-=
height: 16px; text-align: justify;=22>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div>
                                                      <div><span style=3D=
=22font-size:12px;=22>The purpose of the Regulatory inspection is an activi=
ty that should demonstrate that your company is operating according to the =
proper CFR requirements and maintaining a state of compliance=2E The key to=
 a successful audit is being able to communicate how your quality systems a=
ssure this state of control=2E Many times, the arrival of a Regulatory Inve=
stigator is a daunting experience for some=2E</span>
                                                      </div>

                                                      <div><br />
                                                      <span style=3D=22font=
-size:12px;=22>Upon completion of this session, attendees will learn the pr=
oper way to set up for a Regulatory Inspection, ensuring the inspection flo=
ws smoothly throughout the duration, and the proper way to speak to inspect=
ors while they are performing the audit=2E</span>
                                                      </div>

                                                      <div>
                                                      </div>

                                                      <ul>
                                                         <li><span style=3D=
=22font-size:12px;=22>Pre-planning and preparation activities</span></li>
                                                         <li><span style=3D=
=22font-size:12px;=22>What to do when the investigator arrives</span></li>
                                                         <li><span style=3D=
=22font-size:12px;=22>What documents to have ready and on hand</span></li>
                                                         <li><span style=3D=
=22font-size:12px;=22>Assignments and responsibilities for the inspection</=
span></li>
                                                         <li><span style=3D=
=22font-size:12px;=22>A review of Inspection Do's and Don'ts</span></li>
                                                         <li><span style=3D=
=22font-size:12px;=22>The Opening and Close-out Sessions</span></li>
                                                      </ul>
                                                      </div>

                                                      <div><span id=3D=22ck=
e_bm_309C=22 style=3D=22display: none;=22> </span>
                                                      </div>

                                                      <div>
                                                      </div>

                                                      <div><span style=3D=
=22font-size:12px;=22>This webinar, you will learn how to properly alert ke=
y members that an investigator has arrived, the proper protocol for setting=
 up the Inspection room and any associated =93war=94 rooms that will suppor=
t the inspection, and how to manage requests from the investigators in a ti=
mely and accurate manner=2E This preparation minimizes stress and disorder =
during the inspections=2E</span>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>

                                                      <p><span id=3D=22cke_=
bm_306C=22 style=3D=22display: none;=22> </span>
                                                      </p>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </div>
                                                      </td>
                                                   </tr>
                                                </tbody>
                                             </table>
                                             </td>
                                          </tr>
                                       </tbody>
                                    </table>
                                    </td>
                                 </tr>
                                 <tr>
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