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Overview: 1. This course will teach you how to reduce software validation costs by as much as two thirds. 2. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation. 3. The course is highly interactive, using real life examples and proven techniques. 4. You will learn how to use electronic records and electronic signatures to maximize productivity. 5. This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors. 6. The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation. 7. Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters. Day 1 – Agenda Lecture 1: Introduction to the FDA 1. How the regulations help your company to be successful 2. Which data and systems are subject to Part 11? Lecture 2: 21 CFR Parts 11 - Compliance for Electronic Records and Signatures 1. What Part 11 means to you, not just what it says in the regulation. 2. Avoid 483 and Warning Letters. 3. Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. 4. Ensure data integrity, security, and protect intellectual property. 5. Understand the current computer system industry standards for security, data transfer, and audit trails. 6. Electronic signatures, digital pens, and biometric signatures. 7. SOPs required for the IT infrastructure. 8. Product features to look for when purchasing COTS software. 9. Reduce validation resources by using easy to understand fill-in-the-blank validation documents. Lecture 3: HIPAA Compliance for Electronic Records 1. How Part 11 and HIPAA interrelate 2. What are the additional requirements for patient data Lecture 4: The Five Keys to COTS Computer System Validation 1. The Who, What, Where, When, and Why of CSV Lecture 5: The Validation Team 1. How to select team members 2. How to facilitate a validation project Day 2 – Agenda Lecture 6: Ten-Step Process for COTS Computer System Validation 1. Learn which documents the FDA expects to audit. 2. How to use the risk-based validation approach to lower costs. 3. How to link requirements, specifications, risk management, and testing. 4. Document a computer system validation project using easy to understand fill-in-the-blank templates. 5. Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006). Lecture 7: How to Write Requirements and Specifications 1. Workshop for writing requirements and then expanding them for specifications Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise 1. Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation. Lecture 9: Software Testing 1. Reduce testing by writing test cases that trace to elements of risk management. 2. How to write efficient test cases Lecture 10: System Change Control 1. How to manage a validated system with minimal documentation Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk 1. How to save money 2. How to increase quality 3. How to increase compliance with less documentation Lecture 12: Q & A Who Will Benefit: FDA regulated Industries Dietary Supplements Healthcare IT Top and Middle Management Quality Assurance/Management Compliance Management Manufacturing Laboratory Regulatory Affairs Information Technology Marketing & Sales Laboratories Manufacturing facilities About Speaker: David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects. DATE, VENUE & PRICE: Location: Singapore 5th & 6th December 2013 9 AM to 6 PM Venue: Mandarin Orchard Singapore Price: $1,595.00 Register now and save $200. (Early Bird) Until November 10, Early Bird Price: $1,595.00 From November 11 to December 03, Regular Price: $1,795.00 Contact Information: Event Coordinator Toll free: +65-3158-3448 Call our representative TODAY on 1800 447 9407 to have your seats confirmed! Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php EVENT Link – http://bit.ly/HlxzaV Net Zealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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