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.
ChatGPT and Project Management: Leveraging AI for Project M…
Workplace Investigations 101: How to Conduct your Investiga…
Project Management for administrative professionals
The Monte Carlo Simulations in Excel for Risky Investments
Onboarding is NOT Orientation - How to Improve the New Empl…
Dealing With Difficult People: At Work & In Life
Transform Data into Insights: A Beginners Guide to Excel Pi…
Construction Lending And Real Credit Administration: Evalua…
Understanding Accounting for non - Accounting professionals
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
Treating Employees Like Adults: Discipline versus Empowerme…
7 Ways To Beat Burnout: Without Quitting Your Job
How to Write Procedures to Avoid Human Errors
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Proposes Framework to Advance Credibility of AI Models
Ethical Terminations: Navigating Employee Exits with Legal …
Understanding EBITDA – Definition, Formula & Calculation
Project Management for Non-Project Managers - Scheduling yo…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Payments Fraud Detect & Prevent Check, ACH and P-Card Schem…
Managing Toxic & Other Employees Who have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Excel - Pivot Tables - The Key To Modern Data Analysis and …