Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id MLxDIDl7wlqgNQAAInt2oQ ; Mon, 02 Apr 2018 11:49:29 -0700 Return-path: Envelope-to: sandyn@transocean.com Delivery-date: Mon, 02 Apr 2018 11:49:29 -0700 Received: from omp.webcast.compliance4all.com ([129.145.68.202]:60654) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f34WC-0003cc-IT for sandyn@transocean.com; Mon, 02 Apr 2018 11:49:29 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=compliance4all; d=webcast.compliance4all.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=info@webcast.compliance4all.com; bh=NKDC83I+iX+13R4Q5J/AVfgeOLiHlyLaQGx1TH2xTrg=; b=zNFNr4xHC+5o86rx8orQp8N1PRsb62TTpZERZi5RW50sf0iYm8XBe3eOHGYuE5o7lq5mxEpy8gIA 314h3ZqZ45PfRZMEKxTAIokr7P/t73W2O6so1obQThYjrpcvT9bZP3qFajO8PNZVeylgnK7YpVgk VEi/Qcte31A7PWqjnhA= Received: by omp.webcast.compliance4all.com id ho9tj82b6108 for ; Mon, 2 Apr 2018 11:48:44 -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, 2 Apr 2018 11:48:44 -0700 To: sandyn@transocean.com From: =?ISO-8859-1?B?RkRBIFJ1bGUgb24gU3ltYm9scyBpbiBMYWJlbGluZw==?= Reply-To: =?ISO-8859-1?B?RkRBIFJ1bGUgb24gU3ltYm9scyBpbiBMYWJlbGluZw==?= Subject: FDA Issues Final Rule on Symbols in Labeling Feedback-ID: 10656:116342:oraclersys List-Unsubscribe: , X-sgxh1: kHgKPgxljHgkhJLHgQJhu X-rext: 5.interact2.Et8cISGm5zENBBBrbQwdZhULy_VvFtuqRtAtwmxevUi5a1x3 X-cid: netzealou001.46342 Message-ID: <0.0.54.189.1D3CAB339EFA18C.0@omp.webcast.compliance4all.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: View Online Live Webinar FDA Issues Final Rule on Symbols in Labeling REGISTER NOW! FDA says the finale rule is optional, though the agency thinks that it will be a boon to industry and estimates the reduced workload will result in annual savings of up to $25.5 million. Date: Tuesday, April 3, 2018 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: David Dills Overview: The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. Read more... Who Will Benefit: All levels of management and departmental representatives and any anyone who desires a better understanding of the Final Rule, its interpretation and applicability CRO's Regulatory SME's Regulatory Affairs RA Specialists Clinical Affairs Project Leaders for Labeling Operations Quality Control/Quality Assurance Compliance Marketing & Sales Distributors/Authorized Representatives Engineering/Technical Services Consultants Manufacturing Auditors About Speaker: David Dills Global Regulatory Affairs & Compliance Consultant, President. David R. Dills, Global Regulatory Affairs & Compliance Consultant, President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems... Read More Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Toll Free: [...] 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: compliance4all.com] -0.0 RCVD_IN_MSPIKE_H2 RBL: Average reputation (+2) [129.145.68.202 listed in wl.mailspike.net] -0.0 SPF_PASS SPF: sender matches SPF record -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 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 0.0 LOTS_OF_MONEY Huge... sums of money 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> <=21--=5Bif gte mso 9=5D> <=21=5Bendif=5D--><=21--=5Bif = mso=5D> <=21=5Bendif=5D-->
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Live Webinar
FDA Issues Final Rule on Symbols in Labeling
REGISTER N= OW=21
FDA says the finale rule is optional, though the agency thi= nks that it will be a boon to industry and estimates the reduced workload w= ill result in annual savings of up to =2425=2E5 million=2E
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Date: Tuesday, April 3, 2018
Time: 10:00 AM PDT = =7C 01:00 PM EDT
Duration: 60 Minutes<= br /> Instructor: David Dil= ls
Overview:
The Food and Drug Administration (FDA or the= Agency) issued this final rule revising its medical device and certain bio= logical product labeling regulations to explicitly allow for the optional i= nclusion of graphical representations of information, or symbols, in labeli= ng (including labels) without adjacent explanatory text (referred to in thi= s document as =22stand-alone symbols=22) if certain requirements are met=2E= Read more=2E=2E=2E
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Who Will Bene= fit:
  • All l= evels of management and departmental representatives and any anyone who des= ires a better understanding of the Final Rule, its interpretation and appli= cability
  • CRO's=
  • Regul= atory SME's
  • Regul= atory Affairs
  • RA Sp= ecialists
  • Clini= cal Affairs
  • Proje= ct Leaders for Labeling Operations
  • Quali= ty Control/Quality Assurance
  • Compl= iance
  • Marke= ting & Sales
  • Distr= ibutors/Authorized Representatives
  • Engin= eering/Technical Services
  • Consu= ltants
  • Manuf= acturing
  • Audit= ors
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=
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About Speaker= :
David Dills<= /span>
Global Regul= atory Affairs & Compliance Consultant, President=2E
Davi= d R=2E Dills, Global Regulatory Affairs & Compliance Consultant, P= resident, currently provides global regulatory affairs, compliance and qual= ity consultative services for early-stage and established Class I/II/III me= dical device, including combination products, In Vitro Diagnostics, nutrace= uticals/supplements, cosmetics and biopharmaceutical manufacturers in multi= ple medical specialties and therapeutic areas on the global landscape, and = has an accomplished record with more than 26 years of experience in the are= as of Regulatory Affairs, Compliance and Quality Systems=2E=2E=2E Read More
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Compliance4All
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA= =2E
Tol= l Free: +1-800-447-9407
Fax: 302 288 6884
www=2Ecompliance4all=2Ecom =7C Unsubscribe
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