2-day In-person Seminar on Validate Your Own Excel Spreadsheet Application – Workshop at San Francisco
November 20 - 21, 2014 - San Francisco CA USGlobalCompliancePanel
globalcompliancepanel@gmail.com
Phone:8004479407
Course "Validate Your Own Excel Spreadsheet Application - Workshop" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two-day seminar you will learn how to configure Excel applications with the features required for 21 CFR Part 11 thereby 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 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 and other Commercial Off-The-Shelf (COTS) validation projects. Participants must bring their laptop and an Excel application to validate. To get full benefit of this workshop it is best to come with a colleague so you can be your own project team. Who Will Benefit: All Excel users IT QA, QC Laboratory staff Managers, Executives Course Outline: Day 1 – Agenda: Lecture 1: Introductions Lecture 2: Regulations for Electronic Records Lecture 3: 21 CFR Part 11 - Electronic Records & Signatures Lecture 4: Ten-Step Process for Risk-Based Computer System Validation 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 – Agenda: 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 ABOUT SPEAKER - Mr. David Nettleton is a FDA Compliance Specialist, 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. He has completed more than 240 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. Location: San Francisco, CA Date: November 20th & 21st, 2014 Time: 9:00 AM to 6:00 PM PST Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Register now and save $200. (Early Bird) Until October 15, Early Bird Price: $1,295.00 From October 16 to November 18, Regular Price: $1,495.00 Registration Link: http://bit.ly/ValidateYourOwnExcelSpreadsheetApplication Contact Information: NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407 Fax: 302-288-6884 http://www.globalcompliancepanel.com Email: support@globalcompliancepanel.com