Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id YNIgJX9ty1r7OgAAInt2oQ for ; Mon, 09 Apr 2018 06:41:19 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Mon, 09 Apr 2018 06:41:19 -0700 Received: from smtp5.compliance4all.com ([54.38.142.90]:41821) by vps.transocean.com with esmtps (TLSv1.2:ECDHE-RSA-AES256-GCM-SHA384:256) (Exim 4.89_1) (envelope-from ) id 1f5X2l-00041Y-MK for charley@transocean.com; Mon, 09 Apr 2018 06:41:19 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=compliance4All.com; q=dns/txt; s=sarvtes; bh=bWXRb1TY6TJErcw9137zYUA1Q71XNNe2+LC9BPEEBQI=; h=from:reply-to:subject:to:mime-version:content-type:list-unsubscribe; b=0vxOt73IAegSZKEiuMP0hn38mDUsgo50m6QforiIU+Nfp82qpsrQNx647SgrU8X6D8hRzi/ih yPZy+ATW0ZFo0Uqzfo94f5ah7MfXAWscQxDI0XUdsKeUf6X7Zjh+loqKePlBKoRSqn+WUGLC419 pnVPhXPmA4cAo/YhVeRhKVk= Content-Type: multipart/alternative; boundary="_----------=_MCPart_916583528" X-Unique-Id: 6f704109836ce7d232147ab8632d96fe25c5d7d24b85883411dd7689fdd74225db68b6538bf877bede3317ec036449567a322667156f38299d8e7b403f14c2ebd1a34d48aa16d173928074c0fe3f4edf96bee4b77fb5fd84f7fe338e14993ffb15a31510d0918a4312c7d826e5cc04ac4d897c2b6ec9b1c2bbbd33a3afcd86d2 Precedence: bulk X-Feedback-Id: 98525038:5acb67121f2b1d39118b456c.5acb6724de0301211aa65f91:app:mg List-Unsubscribe: , Reply-To: training@compliance4All.com From: FDA 21 CFR Part 11 Enforcement To: charley@transocean.com Subject: FDA's New Enforcement of 21 CFR Part 11 Message-Id: <1523281224912-a157f1ce-93e80ed7-92fbea7c@compliance4All.com> Date: Mon, 09 Apr 2018 13:40:24 +0000 MIME-Version: 1.0 X-Mta-Unique-Id: sttkRnRq.bsRedbnd--71694627-042DD456-BF94-4904-AF66-11DA35A85D4D.14.1 Received: from (127.0.0.1) by smtp5.compliance4all.com id 042DD456-BF94-4904-AF66-11DA35A85D4D.14 for ; Mon, 09 Apr 2018 13:40:27 +0000 (envelope-from ) X-Spam-Status: No, score=0.6 X-Spam-Score: 6 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: FDA's New Enforcement of 21 CFR Part 11Live WebinarFDA's New Enforcement of 21 CFR Part 11REGISTER NOW!The webinar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.Date: Monday, April 30, 2018 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 75 Minutes Instructor: Dr. Ludwig HuberOverview:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. Read more... Who Will Benefit: * QC Managers * QA Managers and Personnel * IT Administrators * Analysts * Regulatory Affairs * Training Departments * Documentation Department * Consultants About Speaker: Dr. Ludwig Huber Director , Labcompliance Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare"... 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: (0.6 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: googleapis.com] 0.5 KAM_NUMSUBJECT Subject ends in numbers 0.0 T_SPF_TEMPERROR SPF: test of record failed (temperror) -0.0 BAYES_40 BODY: Bayes spam probability is 20 to 40% [score: 0.3583] 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 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 0.0 MSGID_FROM_MTA_HEADER Message-Id was added by a relay X-Spam-Flag: NO --_----------=_MCPart_916583528 Content-Type: text/plain; charset=utf-8 Content-Transfer-Encoding: quoted-printable FDA's New Enforcement of 21 CFR Part 11Live WebinarFDA's New Enforcement of= 21 CFR Part 11REGISTER NOW!The webinar will have the answers. In addition,= using industry proven case studies on how to avoid 483 inspectional = observations and warning letters attendees will learn how to prepare their = organization for trouble-free Part 11 related inspections.Date: Monday, = April 30, 2018=20 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 75 Minutes Instructor: Dr. Ludwig HuberOverview:FDA continues to enforce Part 11 = through its new Part 11 inspection and enforcement program. Just in the = last 3 years, FDA issued more than 30 warning letters with Part 11 = violations. Citations are related to inadequate integrity, security and = availability of electronic records but also related to validation of = software and computer systems. There are many questions about the program, = e.g., what inspectors are looking at what are major findings. Read more... Who Will Benefit: * QC Managers * QA Managers and Personnel * IT Administrators * Analysts * Regulatory Affairs * Training Departments * Documentation Department * Consultants About Speaker: Dr. Ludwig Huber Director , Labcompliance Ludwig Huber Ph.D., is the director and editor of Labcompliance the global = online resource for validation and compliance. He is the author of the = books "Validation and Qualification in Analytical Laboratories" and = "Validation of Computerized Analytical and Networked Systems, Informa = Healthcare"... 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_916583528 Content-Type: text/html Content-Transfer-Encoding: quoted-printable
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Live Webinar
FDA's New Enforcement of 21 = CFR Part 11
REGISTER NOW!
The webinar = will have the answers. In addition, using industry proven case studies on = how to avoid 483 inspectional observations and warning letters attendees = will learn how to prepare their organization for trouble-free Part 11 = related inspections.
Date:= Monday, April 30, 2018
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 75 Minutes
Instructor: Dr. Ludwig Huber
Overview:

FDA continues to enforce Part 11 through its new Part = 11 inspection and enforcement program. Just in the last 3 years, FDA issued= more than 30 warning letters with Part 11 violations. Citations are = related to inadequate integrity, security and availability of electronic = records but also related to validation of software and computer systems. = There are many questions about the program, e.g., what inspectors are = looking at what are major findings. Read = more...
 
Who Will Benefit:
  • QC Managers
  • QA Managers and Personnel
  • IT Administrators
  • Analysts
  • Regulatory Affairs
  • Training Departments
  • Documentation Department
  • Consultants
 
About Speaker:
Dr. Ludwig Huber
Director , Labcompliance
Ludwig Huber Ph.D., is the director = and editor of Labcompliance the global online resource for validation and = compliance. He is the author of the books "Validation and = Qualification in Analytical Laboratories" and "Validation of = Computerized Analytical and Networked Systems, Informa Healthcare"... = 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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