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Subject: Document Management for Medical Devices
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 Content preview:  onlinecompliancepanel-webinar-mailer-CHE-DENISE-WRESTLER-MAY03-EB
    Effective Records Management & Document Control for Medical Devices LIVE
   WEBINAR Date: Thursday, 03 May 2018 Time: 10:00 AM PDT | 01:00 PM EDT Call
    510-857-5896 38780 Tyson Lane Suite 210 Fremont, CA-94536 Early Bird Offer!
    Use Promo Code RECD10 to Get 10% off on Recorded Session/CD/Flash Drive/
   Corporate Live Session/Super Combos of this webinar. Offer valid till April
    22, 2018 midnight. Call us to know more. Retention and management of records
    is more complicated than just deciding what to keep and for how long. You
    need to decide in what form should records be kept and should you keep more
    than what the regulations require? In the Medical Device industry, companies
    must "establish and maintain" documents, procedures, and records. This can
    involve huge numbers of documents. Without a system for control, this can
    quickly become burdensome and out of control. This can have disastrous consequences
    in an FDA inspection. This webinar will review the QSR and ISO requirements
    for document control, and provide a streamlined process for document control.
    We will discuss methods and practices that will improve the clarity and control
    of your document control system. Effective GMP documentation practices will
    be reviewed to ensure your paperwork is clear, complete, and easy to understand.
    [...] 
 
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                             [URIs: onlinecompliancepanel.com]
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lor: #006398; text-align:left; text-decoration:none; padding:10px;">
                          <a href=3D"https://www.onlinecompliancepanel.com/=
webinar/Effective-Records-Management-Document-Control-for-Medical-Devices-5=
06540/CHE-DENISE-WRESTLER-MAY03-EB" style=3D"color: #006398;text-decoration=
:none;">Effective Records Management &amp; Document Control for Medical Dev=
ices</a>
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: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; color: #333333; l=
ine-height:16px; padding-bottom:10px; padding-left:10px;">
                          <span style=3D"color:#FF5733;"><strong>LIVE WEBIN=
AR</strong></span><br>
                          <span><strong>Date:</strong> Thursday, 03 May 201=
8</span><br>
                          <span><strong>Time: </strong> 10&#x3a;00 AM PDT &=
#x7c; 01&#x3a;00 PM EDT</span><br>
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ign=3D"middle" style=3D"padding-right:10px;">
                              <a href=3D"https://www.onlinecompliancepanel.=
com/webinar/Effective-Records-Management-Document-Control-for-Medical-Devic=
es-506540/CHE-DENISE-WRESTLER-MAY03-EB"><img src=3D"https://www.onlinecompl=
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ly: Verdana, Arial, Helvetica, sans-serif; font-size: 11px; color: #333333;=
 line-height:16px; text-align:right; padding-right:10px;">Call 510-857-5896=
 <br/> 38780 Tyson Lane Suite 210 Fremont, CA-94536</td>
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                      <span style=3D"font-family:Arial, Helvetica, sans-ser=
if; font-size:13.5px; color:#fff;"><span style=3D"font-size:14px; font-weig=
ht:bold;">Early Bird Offer! </span>Use Promo Code <span style=3D"color:#fff=
; font-family:Arial, Helvetica, sans-serif; font-weight:bold; font-size:16p=
x; border: 1px dashed #fff; padding:0px 5px;"> RECD10</span> to Get 10% off=
 on Recorded Session/CD/Flash Drive/<br/>Corporate Live Session/Super Combo=
s of this webinar.</span>=20
  <span style=3D"font-family:Arial, Helvetica, sans-serif; font-size:12px; =
color:#fff;"> Offer valid till April 22, 2018 midnight. Call us to know mor=
e.</span>
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ign:justify;">
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                        Retention and management of records is more complic=
ated than just deciding what to keep and for how long. You need to decide i=
n what form should records be kept and should you keep more than what the r=
egulations require&#x3f; In the Medical Device industry, companies must &qu=
ot;establish and maintain&quot; documents, procedures, and records. This ca=
n involve huge numbers of documents. Without a system for control, this can=
 quickly become burdensome and out of control. This can have disastrous con=
sequences in an FDA inspection. This webinar will review the QSR and ISO re=
quirements for document control, and provide a streamlined process for docu=
ment control. We will discuss methods and practices that will improve the c=
larity and control of your document control system. Effective GMP documenta=
tion practices will be reviewed to ensure your paperwork is clear, complete=
, and easy to understand. <br/><br/>
=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20
                        <strong>Key Learning Objectives</strong>
                        <ul>
                        <li>Establishing best practice SOP, Deviation, CAPA=
, Change Controls, Complaint and Audit processes</li>
                        <li>Conducting Risk Assessment, Root Cause Analysis=
 and Impact Assessment where appropriate</li>
                        <li>Creating Action Plans, and verifying their effe=
ctiveness</li>
                        <li>Improving efficiencies over the QMS tasks</li>
                        <li>Reducing the risks of manual error</li>
                        <li>Ensuring compliance to 21 CFR Part 11 and immut=
able audit trail</li>
                        <li>Avoid observations, 483 letters and fines</li>
                        <li>Taking the resource burden out of creating dash=
boards/ periodic reports</li>
                        </ul>
=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20
                      </td>
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=3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-serif; fon=
t-size:12px; color:#333333; padding-left:10px;">
						<div style=3D"float: left;padding-top: 7px;">=09
							  <a href=3D"https://www.onlinecompliancepanel.com/webinar/Effective=
-Records-Management-Document-Control-for-Medical-Devices-506540/CHE-DENISE-=
WRESTLER-MAY03-EB" style=3D"color: #006398;">View More</a>
					  </div>
=09=09=09=09=09=20=20
					  <div style=3D"float: right;">
							  <a href=3D"https://www.onlinecompliancepanel.com/webinar/Effective=
-Records-Management-Document-Control-for-Medical-Devices-506540/CHE-DENISE-=
WRESTLER-MAY03-EB/SHARE"><img src=3D"https://www.onlinecompliancepanel.com/=
ocpFiles/ocpImages/theme/temp-share.jpg"></a>
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=09=09=09=09=20=20
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=3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-serif; fon=
t-weight:bold; font-size:16px; color:#333333; padding-left:10px;">
						<div style=3D"width:145%;font-size: 12px;">
=09=09=09=09=09=09
							<div style=3D"background-color:#db1b23; color:#FFFFFF; width:auto; f=
loat:left; padding:6px 10px 6px 10px; margin-right:10px; font-weight:normal=
;">
								<a href=3D"https://www.onlinecompliancepanel.com/webinar/Effective-=
Records-Management-Document-Control-for-Medical-Devices-506540/CHE-DENISE-W=
RESTLER-MAY03-EB" style=3D"color: #ffffff; text-decoration:none;">YES I am =
Attending</a>
							</div>
=09=09=09=09=09=09=09
							<div style=3D"background-color:#e0e3e8; color:#FFFFFF; width:auto; f=
loat:left; padding:6px 10px 6px 10px; font-weight:normal;">
								<a href=3D"https://www.onlinecompliancepanel.com/webinar" style=3D"=
color:#666666; text-decoration:none;">NO I Want a Different Course</a>
							</div>
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                            <td width=3D"50" height=3D"54" align=3D"center"=
 valign=3D"top">
                              <a href=3D"https://www.onlinecompliancepanel.=
com/expert/Denise-Wrestler-28203/CHE-DENISE-WRESTLER-MAY03-EB">
                                <img src=3D"https://www.onlinecompliancepan=
el.com&#x2f;ocpFiles&#x2f;ocpImages&#x2f;speakers&#x2f;28203&#x2f;small.jpg=
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"content" style=3D"color: #666666; font-family: verdana; text-decoration: n=
one; font-size: 12px; 	line-height: 18px; ">
                              <strong>Denise Wrestler</strong><br>
                              <span style=3D"font-size:11px;"></span>Ms.Wre=
stler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC=
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ut wasting precious company resources.</span>
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