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The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: onlinecompliancepanel-webinar-mailer-CHE-DANIEL-LEARY-APR17-EB Acceptance Activities in FDA's Quality Management System LIVE WEBINAR Date: Tuesday, 17 April 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 08, 2018 midnight. Call us to know more. Effective acceptance activities require well-written procedures, trained employees, and correct quality records. In addition, there is a major role that involves sampling, §820.250(b), acceptance status, §820.86, and nonconforming product, §820.90. As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes. [...] Content analysis details: (1.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. 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max-height:1px !important; max-width:1px !important; border:0 !imp= ortant; background-color:transparent !important; padding:0 !important; outl= ine:0 !important; min-height:1px !important; min-width:1px !important; heig= ht:1px !important; width:1px !important;" alt=3D""> <table width=3D"700" border=3D"0" align=3D"center" cellpadding=3D"0" c= ellspacing=3D"0" class=3D"border" style=3D"background-color: #FFFFFF; borde= r-top: 5px solid #CCCCCC; border-bottom: 5px solid #CCCCCC; border-left: 5p= x solid #CCCCCC; border-right: 5px solid #CCCCCC;"> <!--DWLayoutTable--> <tr> <td width=3D"690" height=3D"485" valign=3D"top"><table width=3D"100= %" border=3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> <tr> <td height=3D"197" colspan=3D"2" valign=3D"top"><table width=3D= "100%" border=3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> <tr> <td width=3D"424" height=3D"102" valign=3D"top"><table widt= h=3D"100%" border=3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> <tr> <td width=3D"424" height=3D"auto" valign=3D"top" style= =3D"font-size: 20px; font-family: Verdana, Arial, Helvetica, sans-serif; co= lor: #006398; text-align:left; text-decoration:none; padding:10px;"> <a href=3D"https://www.onlinecompliancepanel.com/= webinar/Acceptance-Activities-in-FDA-s-Quality-Management-System-507314/CHE= -DANIEL-LEARY-APR17-EB" style=3D"color: #006398;text-decoration:none;">Acce= ptance Activities in FDA's Quality Management System</a> </td> </tr> <tr> <td height=3D"auto" valign=3D"top" style=3D"font-family= : 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> Tuesday, 17 April 20= 18</span><br> <span><strong>Time: </strong> 10:00 AM PDT &= #x7c; 01:00 PM EDT</span><br> </td> </tr> </table></td> <td width=3D"266" valign=3D"top"><table width=3D"100%" = border=3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> <tr> <td width=3D"266" height=3D"69" align=3D"right" val= ign=3D"middle" style=3D"padding-right:10px;"> <a href=3D"https://www.onlinecompliancepanel.= com/webinar/Acceptance-Activities-in-FDA-s-Quality-Management-System-507314= /CHE-DANIEL-LEARY-APR17-EB"><img src=3D"https://www.onlinecompliancepanel.c= om/ocpFiles/ocpImages/theme/template-logo.png" alt=3D"OCP_Logo" border=3D"0= "></a> </td> </tr> <tr> <td height=3D"43" valign=3D"top" style=3D"font-fami= 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> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20 <tr> <td height=3D"80" colspan=3D"2" valign=3D"top"> <table width=3D"100%" border=3D"0" cellpadding=3D"0" cellsp= acing=3D"0" bgcolor=3D"#FFFFFF"> <!--DWLayoutTable--> <tr> <td width=3D"690" height=3D"75" align=3D"center" valign= =3D"middle" bgcolor=3D"#1A71B2" style=3D"line-height:22px; background: line= ar-gradient(to right,blue,red);"> <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 08, 2018 midnight. Call us to know mor= e.</span> </td> </tr> <tr> <td height=3D"5"></td> </tr> </table> </td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> </tr> =20=20=20=20=20=20=20=20=20=20 <tr> <td height=3D"373" valign=3D"top"><table width=3D"100%" border= =3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> =20=20=20=20=20=20=20=20=20=20=20=20=20=20 <tr> <td width=3D"424" height=3D"340" valign=3D"top"><table widt= h=3D"424" border=3D"0" cellpadding=3D"0" cellspacing=3D"0"> <!--DWLayoutTable--> <tr> <td height=3D"50" colspan=3D"2" valign=3D"top"><table w= idth=3D"100%" border=3D"0" cellpadding=3D"0" cellspacing=3D"0" style=3D"mar= gin-left:8px;"> <!--DWLayoutTable--> <tr> <td width=3D"142" height=3D"42" align=3D"left" valign= =3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-serif; fon= t-weight:bold; font-size:14px; padding-left:16px; color:#009900;"> <a href=3D"https://www.onlinecompliancepanel.com/= webinar/Acceptance-Activities-in-FDA-s-Quality-Management-System-507314/CHE= -DANIEL-LEARY-APR17-EB" style=3D"color:#ffffff; text-decoration:none;"><img= src=3D"https://www.onlinecompliancepanel.com/ocpFiles/ocpImages/theme/rnr-= button.jpg"/></a> </td> =20=20=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 width=3D"218" align=3D"right" valign=3D"middle" sty= le=3D"font-family:Verdana, Arial, Helvetica, sans-serif; font-size:11px; pa= dding-right:10px; color:#333333;"> <a href=3D"https://www.onlinecompliancepanel.com/ocpF= iles/add-calendar/2017/DANIEL-LEARY-APR17.ics"><img src=3D"https://www.onli= necompliancepanel.com/ocpFiles/ocpImages/theme/add-cal.jpg"></a> <a href=3D"mailto:customersupport@onlinecompliancepan= el.com"><img src=3D"https://www.onlinecompliancepanel.com/ocpFiles/ocpImage= s/theme/temp-email.jpg"></a> </td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> <tr> <td height=3D"339" colspan=3D"2" valign=3D"top" style= =3D"font-family:Verdana, Arial, Helvetica, sans-serif; font-size:12px; colo= r:#333333; line-height:16px; padding-left:10px; padding-right:10px; text-al= ign:justify;"> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 Effective acceptance activities require well-writte= n procedures, trained employees, and correct quality records. In addition, = there is a major role that involves sampling, §820.250(b), a= cceptance status, §820.86, and nonconforming product, §820.90. As= you ensure that your Quality Management System meets FDA's regulation= s, you need robust acceptance activities. A gap could result in a Warning L= etter, but even worse, it could also create a recall. This presentation pro= vides the implementation information as well as the audit strategy to help = verify your processes. <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>Learn some of the specialized terms from QSR</l= i> <li>Understand how purchasing and acceptance activi= ties are linked and combine to facilitate effective supplier management</li> <li>Provide guidance on when in-process acceptance = activities are required</li> <li>Understand the required activities to release a= finished device for distribution</li> <li>Know the acceptance activity records to keep an= d how they relate to Device History Record (DHR)</li> <li>Understand the role of sampling plans in accept= ance activities</li> <li>Know the competence requirements for people who= perform acceptance activities</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> </tr> <tr> <td height=3D"17" colspan=3D"2" align=3D"left" valign= =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/Acceptanc= e-Activities-in-FDA-s-Quality-Management-System-507314/CHE-DANIEL-LEARY-APR= 17-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/Acceptanc= e-Activities-in-FDA-s-Quality-Management-System-507314/CHE-DANIEL-LEARY-APR= 17-EB/SHARE"><img src=3D"https://www.onlinecompliancepanel.com/ocpFiles/ocp= Images/theme/temp-share.jpg"></a> </div> </td> </tr> =09=09=09=09=20=20 <tr> <td width=3D"294" height=3D"35" align=3D"left" valign= =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/Acceptance= -Activities-in-FDA-s-Quality-Management-System-507314/CHE-DANIEL-LEARY-APR1= 7-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> </div> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> <td valign=3D"top"><table width=3D"266" border=3D"0" cellpadd= ing=3D"0" cellspacing=3D"0" bgcolor=3D"#f3f3f3"> <!--DWLayoutTable--> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 <tr> <td width=3D"266" height=3D"71" valign=3D"top"><table= width=3D"100%" border=3D"0" cellpadding=3D"0" cellspacing=3D"0" style=3D"p= adding-top:10px;"> <!--DWLayoutTable--> <tr> <td width=3D"50" height=3D"54" align=3D"center"= valign=3D"top"> <a href=3D"https://www.onlinecompliancepanel.= com/expert/Daniel-O-Leary-25926/CHE-DANIEL-LEARY-APR17-EB"> <img src=3D"https://www.onlinecompliancepan= el.com/images/speakers/25926/daniel_leary_32_40.jpg" al= t=3D"instructor" width=3D"32" height=3D"40" border=3D"0"/> </a> </td> <td width=3D"216" valign=3D"top"><span class=3D= "content" style=3D"color: #666666; font-family: verdana; text-decoration: n= one; font-size: 12px; line-height: 18px; "> <strong>Daniel O'Leary</strong><br> <span style=3D"font-size:11px;"></span>Dan is= the President of Ombu Enterprises, LLC, a company offering training and ex= ecution in Operational Excellence, focused on analytic skills and a systems= approach to operations management. He has more than 30 years experience in= quality, operations, and program management in regulated industries includ= ing aviation, defense, medical devices, and clinical labs.</span> </td> </tr> <tr> <td height=3D"17" colspan=3D"2" align=3D"right" v= align=3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-serif= ; font-size:11px; color:#333333; padding-right:10px; padding-bottom:10px;"> <a href=3D"https://www.onlinecompliancepanel.co= m/expert/Daniel-O-Leary-25926/CHE-DANIEL-LEARY-APR17-EB" style=3D"text-deco= ration:none; color:#3366FF;">View More</a> </td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table></td> </tr> <tr> <td height=3D"84" valign=3D"top"> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 <table width=3D"100%" border=3D"0" cellpadding=3D"0= " cellspacing=3D"0" style=3D"border-top:1px solid #cdcccd;margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width=3D"262" height=3D"30" align=3D"left" = valign=3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-seri= f; font-size:14px; padding-left:10px; color:#333333;">Similar On-Demand Web= inar</td> <td width=3D"4"> </td> </tr> <tr> <td height=3D"auto" valign=3D"top" style=3D"fon= t-family:Verdana, Arial, Helvetica, sans-serif; font-size:11px; padding-lef= t:10px; color:#333333;"> <a href=3D"https://www.onlinecompliancepanel.= com/webinar/Setting-and-Measuring-Quality-Objectives-501634/CHE-DANIEL-LEAR= Y-APR17-EB" style=3D"text-decoration:none; color:#3366FF;">Setting and Meas= uring Quality Objectives</a> </td> <td> </td> </tr> <tr> <td height=3D"25" colspan=3D"2" align=3D"left" = valign=3D"middle" style=3D"font-family:Verdana, Arial, Helvetica, sans-seri= f; font-size:11px; color:#333333; padding-left:10px;"> <a href=3D"https://www.onlinecompliancepanel.= com/campaignSimilarWebinar/507314/CHE-DANIEL-LEARY-APR17-EB/507314-DANIEL" = style=3D"text-decoration:none; color:#3366FF;">View More</a> </td> </tr> </table> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 <table width=3D"100%" border=3D"0" cellpadding=3D"0" = cellspacing=3D"0" style=3D"border-top:1px solid #cdcccd;margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width=3D"262" height=3D"30" align=3D"center" = valign=3D"middle" bgcolor=3D"#CCCCCC" style=3D"font-family:Verdana, Arial, = Helvetica, sans-serif; font-size:14px; padding-left:10px; color:#333333; fo= nt-weight:bold;"> <a href=3D"https://www.onlinecompliancepanel.co= m/resources-sops/CHE-DANIEL-LEARY-APR17-EB" target=3D"_blank"; style=3D"col= or:#0066FF"><span style=3D"color:#CC0000;"><strong>NEW! </strong></span>SOP= Library</a> </td> </tr> </table> </td> </tr> =20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20=20 </table> </td> </tr> =20=20=20=20=20=20=20=20=20=20 </table></td> </tr> <tr> <td colspan=3D"2" style=3D"font-family:Verdana, Arial, Helvetica,= sans-serif; font-size:13px; font-weight:bold; color:#ffffff;" height=3D"40= " valign=3D"middle" align=3D"left"> <a href=3D"https://www.onlinecompliancepanel.com/host-webinar/CHE-DANIEL= -LEARY-APR17-EB" style=3D"color:#ffffff; text-transform:uppercase; float:le= ft; background-color:#77D649; height:40px; width:414px; padding-left:10px;"= > <img src=3D"https://onlinecompliancepanel.com/ocpFiles/ocpImages/theme/ho= st-icon.jpg" style=3D"float:left; padding-top:8px; height:28px; width:30px;= padding-right:10px;"> <span style=3D"float:left; padding-top:13px;">Host T= his Webinar At Your Organization</span></a> =09=09=09 <a href=3D"https://www.onlinecompliancepanel.com/become-speaker/CHE-DANI= EL-LEARY-APR17-EB" style=3D"color:#000; text-transform:uppercase; float:lef= t; width:243px; background-color: #49BAD6; height:40px; padding-top:0px; pa= dding-left:23px;"> <img src=3D"https://www.onlinecompliancepanel.com/ocpFiles/ocpImages/the= me/speaker-icon.png" style=3D"float:left;padding-top:8px;height:20px;width:= 20px; padding-right:8px;"><span style=3D"float:left; padding-top:13px;= ">Become a Speaker</span></a> </td> </tr> <tr> <td height=3D"35" colspan=3D"2" align=3D"center" valign=3D"middle= " bgcolor=3D"#db1b23" style=3D"font-family:Verdana, Arial, Helvetica, sans-= serif; font-size:12px; font-weight:bold; color:#ffffff; padding-left:10px;"> <a href=3D"https://www.onlinecompliancepanel.com/webinar/Acceptance-Act= ivities-in-FDA-s-Quality-Management-System-507314/CHE-DANIEL-LEARY-APR17-EB= " style=3D"color:#ffffff; text-transform:uppercase;">WOULD YOU LIKE TO RESE= RVE YOUR SPOT TODAY AND PAY US LATER? 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