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

LIVE WEBINAR

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

Excel workbooks often support GxP decisions without clear configuration standards, leaving teams to determine what truly requires validation and documented controls. This session establishes a structured approach to configuring spreadsheet applications with built-in controls, aligning security, auditability, and validation scope to 21 CFR Part 11 expectations.

Designed for professionals responsible for electronic records integrity and controlled spreadsheet use within regulated environments.

How This Session Is Structured

The session follows a stepwise configuration of a working spreadsheet, demonstrating security settings, audit trail activation, and data verification controls in real time. It then connects those configurations to validation planning, specification writing, and testing decisions so documentation remains proportionate and clearly justified.

Key Areas Covered:

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.
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

Course Director

David Nettleton

David Nettleton is an FDA compliance specialist focused on 21 CFR Part 11 and computer system validation. With more than 185 software validation projects completed, he brings practical experience configuring and validating regulated applications. His work in gap analysis, remediation, and risk-based validation directly supports controlled spreadsheet implementation in GxP environments.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

For Teams Seeking Deeper Implementation Support

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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