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2-day In-person Seminar on
Validate your own Excel Spreadsheet Application
Course "Validate your own Excel Spreadsheet Application" has been pre-approved by RAPS as eligible for up to 12 credits
towards a participant's RAC recertification upon full completion.
Date & Time: July 26th and July 27th 2012
8 AM to 5 PM EDT
Duration: 2 Days
Instructor: David Nettleton
Location: San Francisco
Price : $1495.00
David Nettleton FDA Compliance Specialist
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" that 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 185 mission critical software validation projects. ...more
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 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:
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Regulations for Electronic Records 21 CFR Part 11 - Electronic Records & Signatures The Risk-Based Validation Approach Excel Applications - part 1
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Day 2: l l
How to Conduct a Hazard Analysis/Risk Assessment Excel Applications - part 2 ¡ ¡
Create a Hazard Analysis document for your application Create a Testing Protocol document for your application
Main Concepts to Remember
Areas Covered in the Session: l l l l l
Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use Excel’s built in 21 CFR Part 11 features. Apply features required for GxP environments without programming macros. Validate your application with minimal documentation. Understand how to use risk assessment to reduce testing and improve productivity. Participate in the workshop as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
Your Necessity is our Priority
Create a User Requirements document for your application Create a Project Plan document for your application Create a Functional Specifications document for your application
Learn how to specify and test your application.
Click here to register for this seminar Who Will Benefit: l
All Excel users
IT QA, QC
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Laboratory staff Managers, Executives
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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In this two day seminar you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance help...