Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id CGk4OFJ+qlrfcwAAInt2oQ for ; Thu, 15 Mar 2018 07:08:18 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Thu, 15 Mar 2018 07:08:18 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:34036 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1ewTXv-0007hP-2U for louk@transocean.com; Thu, 15 Mar 2018 07:08:18 -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=AfYUDnUpma/eD2ctNLNKioWlxfuPVntkQLKArv+JDQg=; b=IUNWU+nAfgom4v8LlAf0jORiW9bCCFWWphGf0pKoBGMRJ/OVpal+SMy4rqBSVBM5vX3OezuQ/DRS Pc9n9wRpkIqq6S5iHNVbCjl7d4rxcuz0OF2xAGq6Zt927olSlhCBvadoEXSj9iy5o1C7mF0xzsRw C/cW4M5LAzYF0jd5pprQmMPCJnchJZGbp785tO7D59JBMqXNJ5DwRkA5GuYdv1pZyU/ERj9XphWL SxWjXf7Zx/Euax3b3iZA+6BUXfYcoxlR2luGeyyYhDlRiN1lPc737MkpLhQcNteDW+fNZFonnouM vmtZ4m2yDOgJRlz2qB06zRkYlzxSqIFPQJR1Fw== Received: by om-axonstech.rsys2.com id hl9v3m2b6109 for ; Thu, 15 Mar 2018 07:07:15 -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: Thu, 15 Mar 2018 07:07:15 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Subject: Verification, Validation, Master Planning for US FDA and ISO 13485 Compliance Feedback-ID: 10775:119022:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EoUAv2gVBuX2KTvBgqOykJ8xxl5V9pZd43Lu9oZoWKgD9yY X-cid: axonstech.124662 Message-ID: <0.1.17F.781.1D3BC66EBF17C4E.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 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: Verification, Validation, Master Planning for US FDA and ISO 13485 Compliance 740-870-0321 Verification, Validation, Master Planning for US FDA and ISO 13485 Compliance [...] Content analysis details: (2.4 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. [URIs: grceducators.com] -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4658] 0.0 HTML_MESSAGE BODY: HTML included in message -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> Verification, Validation, Master Planning for US FDA and ISO 1348= 5 Compliance <=21--=5Bif gte mso 11=5D><=21=5Bendif= =5D--><=21--=5Bif =21mso=5D><=21--> <=21--<=21=5Bendif=5D--><=21--=5Bif gte mso 15=5D>96<=21=5Bendif=5D--><=21--=5Bif gte mso 9=5D>96<=21=5Bendif=5D-->
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740-870-0321
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<= span style=3D=22font-size: 30px;=22>Verification, Validation, Maste= r Planning for US FDA and ISO 13485 Compliance
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TUESDAY, APRIL 17 2018 =7C 01:00 PM EST =7C 90 MIN= UTES
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FDA Warning Let= ters and recent high-profile recalls indicate major cGMP deficiencies in bi= g name device and pharma companies=2E One major failing is lack of sufficie= nt or targeted risk-based Verification and Validation planning and executio= n=2E Another is confusion over terminology=2E
 
How can compani= es address the U=2ES=2E FDA's tougher stance and product, process and QMS V= &V=2E One major failing is lack of sufficient or targeted risk-based V&V Ma= ster Planning=2E Why do companies need a Validation Master Plan? What is it= ? How is it structured? Supporting systems / documents? How should each ind= ividual V&V plan be structured? Clarification of validation terms=2E Device= , product, process, equipment, QMS, software V&V=2E What are the key compon= ents in understandable language? How is it run? What are the =22must have= =22 elements from ISO 14971 and ICH Q9 for hazard analysis and product risk= management? How can these be integrated into a company's QMS?
 
Areas Cov= ered
  • Regulatory =22H= ot Buttons=22
  • V&V Background = and Terms Defined
  • The MVP / VMP
  • Device / Produc= t V&V
  • Drug / Process = V&V
  • Software / firm= ware V&V
  • QMS V&V<= /span>
  • Applicable guid= ance documents
  • Suggested =22Mo= dels=22
  • Data Sources / = Metrics
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REGISTER NOW
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Event Marketing =7C GRC Educators =7C 740-870-0321 =7C support=40grcedu= cators=2Ecom =7C www=2Egrceducators=2Ecom =7C 806 Clark Street, P=2EO Box 1= 71, Philo, OH-43771 USA
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