Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id eBn6HtO0r1rYawAAInt2oQ for ; Mon, 19 Mar 2018 06:02:11 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Mon, 19 Mar 2018 06:02:11 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:40112 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1exuQJ-00079s-W4 for louk@transocean.com; Mon, 19 Mar 2018 06:02:11 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=grceducators; d=news.grceducators.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=grceducators@news.grceducators.com; bh=x9DLrValihJCFx8h+W1Ge/Nkt+9OxEIGIhp1IsIxgb4=; b=JloFrxWJm3KU5Gj/VJSCW64evb+LuoMv6QmNb/SjZNzfbprZ0f9XL3cjJMfk4TaiB6OjVU8bRO9t 17cWZiz8PwVMdw2tsffhnFZn+9WzL85vSa+vbY2xSa1eyTgIFmOFDu4UYgoz7jcjtF+7q7rnw2Rr EpXqKh6aVMNiHhedFjgpZEHRIH2QFLda2/DMLff4tV4pZjIFqtv2/8BZUWzxrk52ifKEyxf0t9Pb LatIsM7jMQYNuI6+gLze1RAJEORydFnc4ub6FAiRJTetLFmvdyjwFrLdxVx0i8fPqAJdJ8n0FtYE k0nTc8eDNQWcVgV6u/sXV2WPJuRIRiKR4JXV5w== Received: by om-axonstech.rsys2.com id hluqcg2b610i for ; Mon, 19 Mar 2018 06:01:20 -0700 (envelope-from ) X-CSA-Complaints: whitelist-complaints@eco.de MIME-Version: 1.0 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable Date: Mon, 19 Mar 2018 06:01:20 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Subject: FDA Compliance and Clinical Trial Computer System Validation Feedback-ID: 10775:126242:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.ElJRd5ngKywICL6qGIRTT_9ZmunugEP12epMc_xxdcBdk18 X-cid: axonstech.129962 Message-ID: <0.1.DF.389.1D3BF825FF5EDDC.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=1.1 X-Spam-Score: 11 X-Spam-Bar: + X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. 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: FDA Compliance and Clinical Trial Computer System Validation 740-870-0321 FDA Compliance and Clinical Trial Computer System Validation [...] Content analysis details: (1.1 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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float: left; width:= 180px;max-width:200px =21important; =22 vspace=3D=220=22 width=3D=22180=22 = /> </div> <div style=3D=22clear= :both;=22> </div> </div> </td> </tr> </tbody> </table> </td> <td class=3D=22rnb-force-col= =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-las= t-col-2=22 valign=3D=22top=22 width=3D=22350=22> <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> </tr> <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> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> <tr> <td height=3D=220=22 style=3D=22font-si= ze:1px; line-height:1px;=22></td> </tr> </tbody> </table> </td> </tr> </tbody> </table> <=21--=5Bif mso 15=5D> </td> <=21=5Bendif=5D--><=21--=5Bif mso 15=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 id=3D= =22Layout_2=22 name=3D=22Layout_2=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=22max-width: 100%; min-width: 100%; table-layout: fixed; border-r= adius: 0px; border-collapse: separate; padding-left: 20px; padding-right: 2= 0px; background-color: rgb(255, 255, 255);=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 width=3D=22550=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=22550=22> <tbody> <tr> <td align=3D=22center= =22 class=3D=22img-block-center=22 valign=3D=22top=22 width=3D=22100%=22> <table border=3D=220= =22 cellpadding=3D=220=22 cellspacing=3D=220=22 width=3D=22100%=22> <tbody> <tr> <td align=3D= =22center=22 class=3D=22img-block-center=22 valign=3D=22top=22 width=3D=221= 00%=22> <table borde= r=3D=220=22 cellpadding=3D=220=22 cellspacing=3D=220=22 style=3D=22display:= inline-block;=22> <tbody> <tr> <td> <di= v style=3D=22border-top:0px None =23000;border-right:0px None =23000;border= -bottom:0px None =23000;border-left:0px None =23000;display:inline-block;= =22> <di= v><a href=3D=22https://news=2Egrceducators=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQ= pglLjHJlTQGtc0KYgndPOb8eAzbEb022XDzdumgmnGySTLifJXzfzfKJ7KsSCVXtpKX%3DTTCCT= &_ei_=3DEq2tf9zs59idfPO1Sc_9BbmtLGFdoihnNpnISoMHnn0iHmOu7xRXfBMRqRHF68L= I1nlATBVrsbwKJc1VzAyuhjc=2E=22 target=3D=22_blank=22><img alt=3D=22=22 bord= er=3D=220=22 class=3D=22rnb-col-1-img=22 hspace=3D=220=22 src=3D=22http://i= mg=2Emailinblue=2Ecom/1620427/images/rnb/original/5a687001e694aa6c2f5d4305= =2Epng=22 style=3D=22vertical-align: top; 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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=22padding-left: 20px; padding-right: 20px; border-collapse: separ= ate; border-radius: 0px; border-bottom-width: 0px; border-bottom-color: rgb= (200, 200, 200); border-bottom-style: none; background-color: rgb(255, 255,= 255);=22 width=3D=22100%=22> <tbody> <tr> <td height=3D=2220=22 style=3D=22font-s= ize:1px; line-height:1px;=22><img height=3D=2240=22 src=3D=22https://static= =2Ecdn=2Eresponsys=2Enet/i2/responsysimages/axonstech/contentlibrary/respon= syssupport/axon/email-offer1=2Epng=22 width=3D=22540=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 style=3D=22text-= align: center;=22><span style=3D=22color:=23000000;=22><span style=3D=22fon= t-size: 17px;=22><strong>MONDAY, APRIL 30 2018 =7C 01:00 PM EST =7C 90 MINU= TES</strong></span></span> </div> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> <tr> <td height=3D=2210=22 style=3D=22font-s= ize: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=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=22padding-left: 20px; padding-right: 20px; border-collapse: separ= ate; border-radius: 0px; border-bottom-width: 0px; border-bottom-color: rgb= (200, 200, 200); border-bottom-style: none; background-color: rgb(255, 255,= 255);=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=22text-= align: justify;=22> <div style=3D=22line-= height:16px;=22> <div> <div> <div> <div> <div> <div> <div> <div> <div><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>The FDA governs= the computer systems used to collect, analyze, transfer and report data th= at is in support of human clinical trials required for drug approval=2E FDA= oversight is based on a Predicate Rule, known as =22Good Clinical Practice= s=22, or simply, =22GCPs=2E=22 Computer systems subject to GCP requirements= must be thoroughly and appropriately validated in accordance with FDA's gu= idance on computer system validation=2E This involves a rigorous set of pha= ses and steps to ensure that, in the language of FDA, =22a system does what= it purports to do=2E=22</span></span> </div> <div> </div>   <div><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22><strong>Learnin= g Objectives</strong></span></span> </div> <ul> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand FDA = requirements for clinical trial Computer System Validation (CSV)</span></sp= an></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand the = System Development Life Cycle (SDLC) approach to validation</span></span></= li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Utilize GAMP 5 = system classification and risk methodologies for categorizing systems and d= eveloping a validation pathway</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand how = to build a complete validation strategy and program for clinical trial syst= ems</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Know how to man= age the validation process and create FDA-compliant documentation</span></s= pan></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Know how to mon= itor a clinical trial system that is in production, governing the data and = system through retirement</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand the = roles and responsibilities required to validate a clinical trial system</sp= an></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Know how to mea= sure cost vs=2E compliance risk for a clinical trial system</span></span></= li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand good= project management principles, incorporating business process re-engineeri= ng and organizational change management into the process</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Know the polici= es and procedures that must be developed and maintained to support the clin= ical trial system in operation</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Understand how = to leverage the vendor and other external resources to apply the best indus= try practices and avoid potential pitfalls when validating a clinical trial= system</span></span></li> <li><span style=3D= =22color:=23000000;=22><span style=3D=22font-size: 12px;=22>Know about FDA = trends in oversight and audit of clinical trial systems and how to keep abr= east of these</span></span></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </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=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 id=3D= =22Layout_17=22 name=3D=22Layout_17=22 style=3D=22min-width:590px; backgrou= nd-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=22min-width:590px; background-= 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=22mso-button-block= rnb-container=22 style=3D=22border-radius: 0px; padding-left: 20px; paddin= g-right: 20px; border-collapse: separate; background-color: rgb(255, 255, 2= 55);=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; 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