Webinar Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance

Faculty - David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation.

Overview

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand how to validate your application with minimal documentation. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs

Session Highlights.

• Develop spreadsheet applications that are GxP compliant

• Learn how to use Excel’s built in 21 CFR Part 11 features

• Apply features required for GxP environments without programming macros.

• Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users

• Validate your application with minimal documentation

• Understand what does and does not need to be validated.

• How to specify and test your application

• Avoid 483s and Warning Letters

• How to use cell and file protections

• Reduce validation time and costs

• Increase compliance while lowering resource needs

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Who Will Benefit

• All Excel users

• IT

• QA

• QC

• Laboratory staff

• Managers

• Executives

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Instructor Profile:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR 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 280 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.

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