Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This webinar provides step-by-step instructions on configuring and validating GxP compliant spreadsheet applications to avoid FDA 483s, focusing on audit trails, security features, and data entry verification, saving time and costs.
Date:
Wednesday, July 2, 2025
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
75 Minutes
More Trainings by this Expert
Product Id : 507098
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.
Areas Covered in the Session:
- 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
- Avoid 483s and Warning Letters
- How to use cell and file protections
- Reduce validation time and costs
- Increase compliance while lowering resource needs
- Validate your application with minimal documentation
- Understand what does and does not need to be validated
- How to specify and test your application
Who Will Benefit:
- All Excel Users
- IT
- QA
- QC
- Laboratory Staff
- Managers
- Executives
Speaker Profile
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.
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