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08 2013

2-day In-person Seminar on “Validate your own Excel Spreadsheet Application” at Washington DC from GlobalCompliancePanel

Syndicated from: Canadian Youth Business Foundation

Overview: In this two-day seminar, you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance, helping you to avoid 483s. Using the risk-based computer system validation approach, you will validate your own Excel application. Use of the validation templates is necessary and important because it typically saves two-thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application validation projects. Course Outline: Day 1 – 27th June 2013 Lecture 1: Introductions Lecture 2: Regulations for Electronic Records Lecture 3: 21 CFR Part 11 – Electronic Records & Signatures Lecture 4: The Risk-Based Validation Approach Lecture 5: Excel Applications – part 1 • Create a User Requirements document for your application • Create a Project Plan document for your application • Create a Functional Specifications document for your application Day 2 – 28th June 2013 Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment Lecture 7: Excel Applications – part 2 • Create a Hazard Analysis document for your application • Create a Testing Protocol document for your application Lecture 8: Main Concepts to Remember Lecture 9: Q&A Who Will Benefit: All Excel users IT QA, QC Laboratory staff Managers, Executives 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: Washington DC | June 27th & 28th, 2013 | 9 AM to 6 PM EDT Venue: Courtyard Washington Capitol Hill/Navy Yard Price: $1,295.00 Register now and save $200. (Early Bird) Until March 29, Early Bird Price: $1,295.00 From March 30 to June 25, Regular Price: $1,495.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: Website: LIVE CHAT SUPPORT ALSO – GlobalCompliancePanel NetZealous LLC 43337 Livermore Common, Fremont CA 94539, USA Click Here:

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