Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id QEglEf1/x1rPMAAAInt2oQ for ; Fri, 06 Apr 2018 07:11:09 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Fri, 06 Apr 2018 07:11:09 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:51405) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f4S4y-0003YT-GS for charley@transocean.com; Fri, 06 Apr 2018 07:11:09 -0700 DKIM-Signature: v=1; a=rsa-sha1; d=email.complianceonline.com; s=ei0; c=simple/simple; q=dns/txt; i=@email.complianceonline.com; t=1523022788; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=SrDdLBCWzzXzEtiub13Ldbu3H/M=; b=KbE2481VIwD21F/9SeBlPME30rhwUeMDX5ydvzpfRmwnk3LXvby5IQG5mKVv0vqw gLmL5UTxRlN2O21arT5xJpdPjDZuXT7LLfcK91hglQyxgIQIKF7XXfy0jyE1QtcZ x7CyynzBi1/dI+lKZhgxF2fBkZXCtNHCjDoCh7sshNA=; Received: from [10.21.250.231] ([10.21.250.231:1835] helo=CORE18PUMPER1) by pc1udsmta1n13 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id 63/3B-05611-4CB77CA5; Fri, 06 Apr 2018 09:53:08 -0400 Date: Fri, 06 Apr 2018 22:53:08 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnjAQZ8uLYlyMYAUtkUt4De8UZS4tCVgJFV4EXG9As2khkZwOI6U= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Computer System Validation - Reduce Costs & Avoid 483s; Boston, MA, April 25-26, 2018 MIME-Version: 1.0 Content-Type: text/html; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Spam-Status: No, score=1.9 X-Spam-Score: 19 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 :: Web Seminar +1-888-717-2436 2-Day In-Person Seminar Computer System Validation - Reduce Costs and Avoid 483s Location 1: Courtyard by Marriott Boston-Cambridge, MA | April 25-26 Location 2: DoubleTree by Hilton San Diego Downtown, CA | June 12-13 One Registration - USD 1299 Register here Course Description: This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Medical Device Summit San Francisco, CA, June 7-8, 2018 REGISTER EARLY Learning Objectives: Understand what is expected in Part 11 and Annex 11 inspections Avoid 483s and Warning Letters Learn how to buy COTS software and qualify vendors Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe Download Seminar Brochure Agenda: Day 1 Introduction to the FDA (1 hr) 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hr) HIPAA Compliance for Electronic Records (30 minutes) The Five Keys to COTS Computer System Validation (30 minutes) The Validation Team (30 minutes) Day 2 Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr) How to Write Requirements and Specifications (30 minutes) How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 minutes) Software Testing (1 hr) System Change Control (30 minutes) [...] Content analysis details: (1.9 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.5 KAM_NUMSUBJECT Subject ends in numbers 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 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4999] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 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 X-Spam-Flag: NO ComplianceOnline :: Web Seminar
ComplianceOnline
ComplianceOnline
+1-888-717-2436
  2-Day In-Person Seminar
Computer System Validation - Reduce Costs and Avoid 483s		  
  Location 1: Courtyard by Marriott Boston-Cambridge, MA | April 25-26
Location 2: DoubleTree by Hilton San Diego Downtown, CA | June 12-13
  One Registration - USD 1299 Register here  
  Course Description:
  This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
Medical Device Summit
San Francisco, CA,
June 7-8, 2018
REGISTER EARLY
  Learning Objectives:
 
  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s and Warning Letters
  • Learn how to buy COTS software and qualify vendors
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe
 
  Download Seminar Brochure  
  Agenda:
 
Day 1
  • Introduction to the FDA (1 hr)
  • 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hr)
  • HIPAA Compliance for Electronic Records (30 minutes)
  • The Five Keys to COTS Computer System Validation (30 minutes)
  • The Validation Team (30 minutes)
Day 2
  • Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
  • How to Write Requirements and Specifications (30 minutes)
  • How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 minutes)
  • Software Testing (1 hr)
  • System Change Control (30 minutes)
  • Purchasing COTS Software (30 minutes)
  • Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
 
  Download Detailed Agenda  
  Meet Your Instructor:
  David Nettleton,
FDA Compliance Specialist, Computer System Validation

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. (Read more) 		 
  Venue:
 
Location 1:
Boston, MA | April 25-26, 2018
Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA, 02139, United States
 Location 2:
San Diego, CA | June 12-13, 2018
DoubleTree by Hilton San Diego
Downtown, 1646 Front Street
San Diego, California, 92101, USA
 
 
One Registration - USD 1299 Register here
 
  Your registration fee includes the workshop, all course materials and lunch.
  
  Please forward this email to your friends or colleagues  
Medical Device Summit 2018
June 7-8, 2018 | San Francisco, CA
REGISTER NOW AND SAVE!
SPACE IS LIMITED. REGISTER EARLY.
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