This interactive webinar explains how to configure and validate 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.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
David Nettleton
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 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Leadership: Strategic Planning and Decision Making
4-Hour Virtual Seminar on Transformational Leadership - The…
Workplace Investigations 101: How to Conduct your Investiga…
Copilot and HR: An Introduction for HR Professionals
Negotiating Skills For Professional Results - Winning Strat…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Managing Complex Projects - Project Management
Managing Toxic Employees: Strategies For Leaders To Effecti…
Excel Power Skills: Master Functions, Formulas, and Macros …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Using High-Performance Coaching for Managers to Address Per…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Understanding Artificial Intelligence (AI) & using Chat GPT
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Creating Your 2025 Marketing Strategy
Enhance Your Confidence and Leadership Presence
Trust in Leadership: Building and Maintaining Trust as a Le…
Effective Communication Skills It’s Not What You Say, But H…
2026 Handbook Overhaul: Navigating Critical Updates! Does t…
From Concept to Creation: Strategies for Cultivating Workpl…
Mastering Performance Management: Strategies for Continuous…
2025 EEOC & Employers: Investigating Claims of Harassment …
Project Management for administrative professionals
The Importance of the first 5 seconds when presenting
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
Changing Behavior: Why Rewards and Punishments Often Aren't…
Pivot tables beginner to advanced + 20 advanced Pivot table…
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Managing Toxic & Other Employees Who Have Attitude Issues
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Employee Handbooks: 2025 Critical Issues