Learn how to configure and validate GxP compliant Excel applications — step by step — to avoid FDA 483s and Warning Letters without writing a single macro.
Includes live access & recording
This interactive webinar by industry expert David Nettleton explains how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications.
You will follow step-by-step instructions in real time as the instructor configures Excel for audit trails, security features, and data entry verification. The session gives you a solid understanding of how to validate your application with minimal documentation.
It is advised to bring your laptop and use Excel alongside the presenter for your own hands-on practice. This session will help you save time and cost and make you a superior Excel user in regulated environments.
Spreadsheets are among the most commonly cited tools in FDA 483 observations. Despite being widely used across regulated laboratories and quality departments, most Excel implementations lack the audit trails, access controls, and validation documentation regulators expect.
This session equips you with the specific Excel features and configuration steps needed to meet 21 CFR Part 11 requirements — without any programming or macros.
Walk away with actionable, inspection-ready practices you can apply the same day.
Eleven practical objectives covering the full lifecycle of compliant Excel spreadsheet development and validation.
How to develop GxP compliant spreadsheet applications.
Learn how to use Excel's built-in 21 CFR Part 11 features.
Apply features required for GxP environments without programming macros.
Configure Excel for audit trails, security features, data verification, and multiple concurrent users.
Avoid 483s and Warning Letters through proper spreadsheet governance.
How to use cell and file protections effectively.
Reduce validation time and costs without sacrificing compliance.
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 for regulatory acceptance.
Four focused areas that will transform how your team manages Excel in regulated environments.
Learn to configure Excel with the built-in settings needed for GxP compliance — audit trails, access controls, and data entry verification — no macros required.
Step-by-step guidance on enabling Excel's security features, cell and file protections, and audit trail capabilities that satisfy 21 CFR Part 11 requirements.
Discover a minimal-documentation validation approach that satisfies FDA expectations while dramatically reducing the time and resources your team spends on compliance.
Understand the common spreadsheet gaps that trigger FDA 483 observations and Warning Letters — and the specific steps to close them before your next inspection.
Anyone in a regulated environment who creates, uses, or oversees Excel spreadsheets in quality, laboratory, or compliance operations.
All Excel Users in Regulated Environments
QA Departments
QC Departments
IT Departments
Laboratory Staff
Managers and Executives
Microsoft Excel remains one of the most widely used tools in regulated industries — from laboratory data analysis and batch record calculations to quality metrics and trending reports. Yet despite its ubiquity, Excel is also one of the most frequently cited sources of data integrity violations in FDA inspections.
Under 21 CFR Part 11, any electronic records and electronic signatures used in regulated activities must meet specific requirements for audit trails, access controls, data security, and system validation. Many organizations run Excel spreadsheets that lack these controls entirely — creating significant regulatory exposure without realizing it.
This webinar addresses that gap head-on. Rather than replacing Excel, it shows participants how to leverage the compliance features already built into the software — configuring them correctly to meet GxP expectations, reduce validation burden, and produce documentation that satisfies FDA investigators during inspections. The result is a more compliant, more efficient, and more defensible use of a tool your team already relies on every day.
David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book, Risk Based Software Validation – Ten Easy Steps, addresses 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. David has completed more than 185 mission-critical software validation projects across the pharmaceutical, biotech, and medical device sectors.
His practical, no-nonsense approach to compliance — focused on achieving regulatory requirements with minimal unnecessary burden — has made him a trusted resource for organizations seeking to strengthen their computer system validation programs efficiently and effectively.
Join David Nettleton for this hands-on training and leave with actionable steps to make your Excel spreadsheets fully 21 CFR Part 11 compliant.