Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id CDUpNaa7r1r+dQAAInt2oQ for ; Mon, 19 Mar 2018 06:31:18 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Mon, 19 Mar 2018 06:31:18 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:54168 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1exusf-00088H-2k for louk@transocean.com; Mon, 19 Mar 2018 06:31:18 -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=1umIve4iVSnED6W9/Y3iJPo4JiTgwg/tsCsQpy+NDiI=; b=mz4m2OaZxn4LxkjcoR1Mn9KI5lr9Vq+MkC5FXkgd2krmNCzCyRW9VUA0wUW+T1wj0Vd+ft9/I6UT SuWf9crOLV54nvECv7usN4EHNiprW9JOGhhzffgIDu9KmvE71R8hVwrHVoNEOaFOwCeY61NvbAUQ Wf17BURFKc0b484+DZU6O5OKLeKLYmdUOA6fQ45s8HzHgTsHMp0ZJGLLHLWEr0G9KWb4b1nPZMmV HjhY8KOH8Rx+1Czu7z+bB+02NHiFL2A7V+hjKtzqp+2Vaabiy4LSRLYeBWA36jDwxoUvHwYcXj// /xPIwY9slY0YrJIwX+InmY884GoUtlrwojJMhQ== Received: by om-axonstech.rsys2.com id hlutqa2b610p for ; Mon, 19 Mar 2018 06:30:37 -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 06:30:37 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: Scrutinizing Test Method Validation(TMV) to Verify the Performance of a Medical Device Feedback-ID: 10775:126282:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.El_tMnDX0RavD_kjY6TiSHd5Y9ZXzuQ0htJZGAKI9mIqbVQ X-cid: axonstech.128822 Message-ID: <0.1.30F.F82.1D3BF86774A7238.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=1.6 X-Spam-Score: 16 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: TMV to Verify the performance of a Medical Device 740-870-0321 Scrutinizing Test Method Validation(TMV) to Verify the Performance of a Medical Device [...] Content analysis details: (1.6 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: mailinblue.com] -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background -0.0 BAYES_40 BODY: Bayes spam probability is 20 to 40% [score: 0.3683] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts -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> TMV to Verify the performance of a Medical Device <=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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Scrutinizing Test Method Validati= on(TMV) to Verify the Performance of a Medical Device
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WEDNESDAY APRIL 11 2018  =7C 01:00 PM EST&nbs= p; =7C 90 MINUTES
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Test method validation is an often-confusing requirem= ent for medical devices=2E A fundamental issue is the role-reversal between= the test method and the product or process it is designed to detect=2E For= example, while a defect-free process is desirable, a test method must be r= eliable both in detecting defects and in not rejecting acceptable samples= =2E Those who work with process optimization and validation focus on optimi= zing a process and reducing variability=2E Those working on Test Method Val= idation, on the other hand, focus on discerning between process variation a= nd measurement error from the test method itself=2E

Often, the test method for a new process must be designed sp= ecifically for that process, and some of the pitfalls are in confounding th= e process itself with the test method=2E This webinar will present case-stu= dies to explore how those issues are addressed=2E

Although the FDA provides guidance on method validation, the= Code of Federal Regulations (CFR) Title 21 Part 820: Quality System Regula= tion (QSR) 21 does not specifically broach the topic of method validation= =2E It alludes to it in equipment qualification, statistical methods, proce= ss validation, design controls, and other sections=2E In numerous warning l= etters, we have witnessed significant importance of method validation as an= applicable medical device validation activity=2E Although, some traditiona= l methods have been applied to chemical, microbial and laboratory acceptanc= e testing methods, they are generally less utilized in the medical device i= ndustry=2E
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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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