Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id uMctFtxy11ofVQAAInt2oQ for ; Wed, 18 Apr 2018 09:31:24 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Wed, 18 Apr 2018 09:31:24 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:35676 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f8pzJ-0005mW-8w for louk@transocean.com; Wed, 18 Apr 2018 09:31:24 -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=g/K8UWsIBcIdExV8O+XgpDyPd9NcDXLPHdUcS1gyGkU=; b=aDIzXCJylJXzBidUJYTi5Nlxv8PXNK1LnvPkGGfPIXgoNboLPNmqc/n/TduQejMCKQcgGX7uBNL0 dYEuvgnRJyQFWETIl/oXvp0zIOXRcM7TBlUjm5n2v0Qo8SIBZXmyCCEMb1dzXi0uKTNnT7OOGPA6 cYIHUC+sIcfcSPgkLj/8mctn3pAivpCvkMqO2Z7rbdAtFltnA/f1N8qvZ1W8JGg8fx5wtb3HHN+E 4sAGzrszTIbKd/527Sc05RXjzJKn6g2TjNobhJAi45WzYgGeS438bIe7ASGVjcpc2yzT6HQbgpMI HWikTu4neuU60sngSbZPCKqdjo/kG3EHMEhghA== Received: by om-axonstech.rsys2.com id hqtpdc2b6100 for ; Wed, 18 Apr 2018 09:30:37 -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: Wed, 18 Apr 2018 09:30:37 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: Medical Device Complaints and Corrective and Preventative Action (CAPA) Feedback-ID: 10775:175122:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.Enp-9VE40JGC2ZcLrvJgqdQq1vw7Zd3fJgjhU5vjQ6SNwiM X-cid: axonstech.169262 Message-ID: <0.1.8F.DC3.1D3D7329574234E.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: Medical Device Complaints and Corrective and CAPA 740-870-0321 Medical Device Complaints and Corrective and Preventative Action (CAPA) [...] 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 SPF_PASS SPF: sender matches SPF record 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.0 HTML_MESSAGE BODY: HTML included in message 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature -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 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> Medical Device Complaints and Corrective and CAPA <=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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Medical Device Complaints and Cor= rective and Preventative Action (CAPA)
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WEDNESDAY, MAY 09 2018 =7C 01:00 PM EST =7C 60 MIN= UTES
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Complaint handling and Corrective and Preventative Ac= tion (CAPA) is considered by the FDA to be two of the most important areas = to assure medical device safety and efficacy=2E They are in the top five ar= eas where FDA finds problems during inspections and issues 483=92s=2E Medic= al device developers must understand the complicated Complaint and CAPA pro= cess and have a strong CAPA program=2E A key understanding is striking a ba= lance between too many CAPA=92s (strangles the system) and too few (problem= areas escape fixing)=2E
 
Learning Objectives:
  • Sources of information (complaints)
  • Information gathering & proactive information gatheri= ng
  • Information evaluation (is it a Complaint, is it a CA= PA, should it be investigated)
  • Risk analysis applied to CAPA
  • Root cause determination
  • CAPA Investigation Report & CAPA action Plan
  • Verification/ Validation of CAPA action
  • Post-closing effectiveness check
  • CAPA program metrics
This webinar will explain the CAPA process from infor= mation gathering through MDR and Recall decision making to final CAPA closi= ng=2E Post-closing effectiveness evaluation is required and will be explain= ed=2E Preventative Action is often neglected and will be discussed=2E Post = distribution product monitoring including customer surveys will be explaine= d=2E Integration of manufacturing non-conformities with the CAPA program wi= ll be discussed=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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© 2018 GRC Educators
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