Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id CARkMOm43FrjeAAAInt2oQ for ; Sun, 22 Apr 2018 09:31:37 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Sun, 22 Apr 2018 09:31:37 -0700 Received: from c98.compliance4all.com ([188.165.49.98]:55470) by vps.transocean.com with esmtps (TLSv1.2:ECDHE-RSA-AES256-GCM-SHA384:256) (Exim 4.89_1) (envelope-from ) id 1fAHth-00083U-45 for charley@transocean.com; Sun, 22 Apr 2018 09:31:37 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=compliance4All.com; q=dns/txt; s=sarvtes; bh=vQuIQy93U8li8sU7iZzbJkPVKofSaiwz3+QvumjWoiE=; h=from:reply-to:subject:to:mime-version:content-type:list-unsubscribe; b=32O0ZIVNWytB4GzcqDq80gLuxqxZjGvtwAW9Bc9MxQJSVW62LIsAib4gWcgrp1rlG4DHJsWjk Fh58zF+jheNqlngxHbAb5IW/eSxwdO6dM4m49g39q+39qG0zefKd9Ny9gMAGD7Aiocns4eGm0Lx HEAzYyNPfGFD4+qT7RrynLY= Content-Type: multipart/alternative; boundary="_----------=_MCPart_299737804" X-Unique-Id: 6f704109836ce7d232147ab8632d96fee8d39afd399dce727e60b211bd5b839cc9214fb2fb1a5bffccca2eea5ec1009c10a45cf7bebe861f278f7e611df3c523b8c4d8e50809e20149a4e0a824f7efbc7c2ca0f2209df15703e301df7e3a8b513990e906bfd58a7387bb01eafb97986b2c95d6413a0e57372338165ed2af98cb Precedence: bulk X-Feedback-Id: 69625414:5adca9921f2b1d65428b456d.5adca9ed3417695c4b41ea77:app:mg List-Unsubscribe: , Reply-To: training@compliance4All.com From: "DHR - Key Requirements" To: charley@transocean.com Subject: Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements Message-Id: <1524414609551-6abfbd3a-5b41decd-e9a25cd3@compliance4All.com> Date: Sun, 22 Apr 2018 16:30:09 +0000 MIME-Version: 1.0 X-Mta-Unique-Id: tetttbse.ktddnqdb--72828047-A174195C-395C-458A-8D8D-A844B89EFAC2.55.1 Received: from (127.0.0.1) by c98.compliance4all.com id A174195C-395C-458A-8D8D-A844B89EFAC2.55 for ; Sun, 22 Apr 2018 16:30:47 +0000 (envelope-from ) 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: Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements A??Live WebinarDesign History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements REGISTER NOW!The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development.Date: Wednesday, April 25, 2018 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: John E LincolnOverview:It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Read more... Who Will Benefit: * Senior Management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D * Engineering * Production * Operations * Marketing About Speaker: John E Lincoln Consultant, Medical device and Regulatory affairs John E. Lincoln, is a medical device and rewgulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses... Read More Compliance4All161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.Toll Free: +1-800-447-9407Fax: 302 288 6884 www.compliance4all.com Copyright © 2017 compliance4All. All rights reserved.. [...] 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: googleapis.com] 1.5 SPF_SOFTFAIL SPF: sender does not match SPF record (softfail) 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.0 HTML_MESSAGE BODY: HTML included in message 0.2 KAM_TRACKIMAGE RAW: Message has a remote image explicitly meant for tracking -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 0.0 MSGID_FROM_MTA_HEADER Message-Id was added by a relay X-Spam-Flag: NO --_----------=_MCPart_299737804 Content-Type: text/plain; charset=utf-8 Content-Transfer-Encoding: quoted-printable Design History Files (DHF), Device Master Records (DMR), Device History = Records (DHR), Technical Files , Design Dossiers - The Requirements A??Live= WebinarDesign History Files (DHF), Device Master Records (DMR), Device = History Records (DHR), Technical Files , Design Dossiers - The Requirements= REGISTER NOW!The importance and usefulness of the "Essential = Requirements"; Structure of the "Declaration of Conformity"; self-declaring= or N-B reviewed; Parallel approaches to development.Date: Wednesday, April= 25, 2018=20 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: John E LincolnOverview:It will also consider the European = Union's MDD TF/DD requirements, and evaluate the documents' differing = purposes / goals, as well as the two different device classification = schemes. Required and desirable contents will be discussed. Read more... Who Will Benefit: * Senior Management in Drugs, Devices, Biologics, Dietary= Supplements * QA * RA * R&D * Engineering * Production * Operations * Marketing About Speaker: John E Lincoln Consultant, Medical device and Regulatory affairs John E. Lincoln, is a medical device and rewgulatory affairs consultant. He= has helped companies to implement or modify their GMP systems and = procedures, product risk management, U.S. FDA responses... Read More Compliance4All161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.= Toll Free: +1-800-447-9407Fax: 302 288 6884 www.compliance4all.com Copyright =C2=A9 2017 compliance4All. All rights reserved.. --_----------=_MCPart_299737804 Content-Type: text/html Content-Transfer-Encoding: quoted-printable
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Live Webinar
Design History Files (DHF), = Device Master Records (DMR), Device History Records (DHR), Technical Files = , Design Dossiers - The Requirements
REGISTER NOW!
The = importance and usefulness of the "Essential Requirements"; = Structure of the "Declaration of Conformity"; self-declaring or = N-B reviewed; Parallel approaches to development.
Date:= Wednesday, April 25, 2018
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Overview:
It will also consider the European Union's MDD TF/DD = requirements, and evaluate the documents' differing purposes / goals, = as well as the two different device classification schemes. Required and = desirable contents will be discussed. Read more...
 
Who Will Benefit:
  • Senior Management in Drugs, Devices, Biologics, = Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing
 
About Speaker:
John E Lincoln
Consultant, Medical device and Regulatory affairs
John E. Lincoln, is a medical device = and rewgulatory affairs consultant. He has helped companies to implement or= modify their GMP systems and procedures, product risk management, U.S. FDA= responses... Read More
 
 
Compliance4All=
161 Mission Falls Lane, = Suite 216, Fremont, CA 94539, USA.
Toll Free: +1-800-447-9407
Fax: 302 288 6884
www.compliance4all.= com
 
Copyright © 2017 compliance4All. All rights reserved.

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