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Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance

Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.

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1.25 hoursThursday, August 6, 2026
David Nettleton

Instructor

David Nettleton

FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation

What You'll Learn

Develop GxP compliant spreadsheet applications in Excel
Use Excel's built-in 21 CFR Part 11 features without programming macros
Configure Excel for audit trails, security features, and data entry verification
Apply cell and file protections for multi-user GxP environments
Validate your Excel application with minimal documentation
Understand what does and does not need to be validated
Reduce validation time and costs while increasing compliance
Avoid FDA 483s and Warning Letters related to spreadsheet use

About This Event

This interactive webinar by industry expert David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a good understanding on how to validate your application with minimal documentation. It is advised to bring your laptop and use Excel for your own needs. This session will help you save time and cost and make you a superior Excel user. Code: FDB3451

Curriculum

GxP Compliant Spreadsheet Development Overview
10 min
Excel's Built-in 21 CFR Part 11 Features
10 min
Configuring Audit Trails in Excel
12 min
Security Features and Data Entry Verification
10 min

Requirements

  • Working in a regulated environment (pharma, medical device, lab, or similar)
  • Basic Excel familiarity — no programming or macro experience required
  • Bring your laptop with Excel installed for hands-on follow-along

Who Should Attend

All Excel users in regulated environments, QA Departments, QC Departments, IT Departments, Laboratory Staff, Managers, and Executives in pharmaceutical, medical device, biotech, and other FDA-regulated industries.

Areas Covered

Developing GxP compliant spreadsheet applications
Using Excel's built-in 21 CFR Part 11 features
Applying features for GxP environments without programming macros
Configuring Excel for audit trails, security, data verification, and multiple users
Avoiding 483s and Warning Letters
Cell and file protections
Reducing validation time and costs
Validating applications with minimal documentation
Understanding what does and does not need validation

Meet Your Instructor

David Nettleton

David Nettleton

FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation

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", relating 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.

21 CFR Part 11 Specialist185+ Validation ProjectsHIPAA Compliance ExpertPublished Author
Quantity
1

Live – Single

$299.00
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Certificate of completion

Event Details

Format

Live Webinar

Duration

1.25 hours

Certificate

Included

Date

Thursday, August 6, 2026

Topics

Excel21 CFR Part 11Data IntegrityGxPSpreadsheet ValidationFDA 483CSVAudit Trail

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