Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id oJaSGCXu2VoVawAAInt2oQ for ; Fri, 20 Apr 2018 06:41:57 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Fri, 20 Apr 2018 06:41:57 -0700 Received: from mta034b.pmx1.epsl1.com ([142.54.244.34]:19484) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f9WIH-0007Iu-Q6 for charley@transocean.com; Fri, 20 Apr 2018 06:41:57 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=simple/simple; d=info.complianceonline.com; s=ep1; t=1524231663; bh=BWlLyiC8kMJmhPeRQhnOqZoWQaxJIdMpP8AFvIdv/jE=; h=MIME-Version:Subject:From:To:Date:Content-Type; b=BUaMqyXjIJ9K+uOqqvFKDkT/7+WcmGvmXFwIZr1LMfHiQ8G8qdYMZd8KKCeP7CA9C oxofN2nGEUiLqz3//wr/AkddcA29LDEQ26fgbYlC1a/PG+hnMfmg7Lm+3kvhZIO6F4 JpwG0keBzI7Bf1EmSp5zbLTSPodl855c90t5i5X8= Received: from [10.233.19.185] ([10.233.19.185:34704]) by pc1udsmtn1n16 (envelope-from ) (ecelerity 3.6.9.48312 r(Core:3.6.9.0)) with ECSTREAM id 5F/3E-06937-FEDE9DA5; Fri, 20 Apr 2018 13:41:03 +0000 List-Unsubscribe: Message-ID: MIME-Version: 1.0 Reply-To: "training@info.complianceonline.com" Subject: 21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s From: Compliance Training To: charley@transocean.com Date: Fri, 20 Apr 2018 13:41:03 +0000 Content-Type: multipart/alternative; boundary="-=Part.2c6e035.d70704a42f8fc9f4.162e3497143.126d8ac13ec2d1c3=-" X-Spam-Status: No, score=2.2 X-Spam-Score: 22 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: ComplianceOnline ComplianceOnline The Largest GRC Advisory Network +1-888-717-2436 21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s Monday, April 23, 2018 | 10:00 AM PDT (60 Min) • View Details Speaker: David Nettleton, FDA Compliance Specialist, ComputerSystemValidation This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All required IT SOPs will be described. Product features based on the current industry standards will be explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood. [...] Content analysis details: (2.2 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: complianceonline.com] -0.0 SPF_PASS SPF: sender matches SPF record 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: 0.4808] 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 MPART_ALT_DIFF BODY: HTML and text parts are different 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 0.0 MIME_HTML_ONLY_MULTI Multipart message only has text/html MIME parts X-Spam-Flag: NO ---=Part.2c6e035.d70704a42f8fc9f4.162e3497143.126d8ac13ec2d1c3=- Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset=UTF-8 ComplianceOnline
ComplianceOnline
The Largest GRC Advisory Network 		+1-888-717-24= 36
21 CFR Part 1= 1 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Monday, April 2= 3, 2018 | 10:00 AM PDT (60 Min) =E2=80=A2 View Details
Speaker= : David Nettleton, FDA Compliance Specialist, Com= puterSystemValidation

This webinar will describe exactly what is required for compliance = with Part 11 and the updated European equivalent Annex 11=2E It will take t= he concepts described in the regulations and expand them into specifics for= all three primary compliance areas: SOPs, product features, and validation= =2E Attendees will learn what is required for IT, SaaS, and cloud hosting= =2E All required IT SOPs will be described=2E Product features based on the= current industry standards will be explained in detail=2E The 10-step risk= -based validation approach is outlined so that the specific documents for a= validation project are understood=2E

Areas Covered: =
  • Which data and systems are subject to Part 11 and Annex 11
  • What the regulations mean, not just what they say
  • Avoid 483s and Warning Letters
  • Explore the three primary areas of compliance: SOPs, software product = features, and validation documentation
  • Learn the requirements for IT, SaaS, and cloud hosting
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security= , data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-bl= ank validation documents
Register Now

Registration Information:
One Dial-in One Attendee
$229
Group - Max=2E 10 Attendees/Location
$459

Speaker Profile:

Computer System Val= idation's principal, David Nettleton, is an industry leader, author, and in= structor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software = validation, and computer system validation=2E He is involved with the devel= opment, purchase, installation, operation and maintenance of computerized s= ystems used in FDA compliant applications=2E He has completed more than 250= mission critical laboratory, clinical, and manufacturing software implemen= tation projects=2E
View Details
4th Annual Medical Device Summit 2018 | San Franc= isco, CA | June 7-8, 2018
=C2=A9 Copyright 2018 | 2479 East Bayshore Road, Suite 200 = Palo Alto, CA 94303, USA | +1-888-717-2436
This message was sent to charley@transocean=2Ecom | Unsubscribe=2E
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