247Compliance

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance

Learn valuable insights and strategies from industry experts.

  • Expert-led Training
  • Industry Best Practices
  • Practical Implementation
  • Real-world Scenarios
David Nettleton

Speaker: David Nettleton

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Date
18 March, 2025 (Tuesday)
Time
12:00 PM PDT | 03:00 PM EDT
Duration
75 Minutes Minutes

Overview

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.

Why Should You Attend

  • Develop spreadsheet applications that are GxP-compliant.
  • 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.

Who Will Benefit?

  • All Excel users.
  • IT.
  • QA.
  • QC.
  • Laboratory staff.
  • Managers.
  • Executives.
  • Auditors.
  • GMP, GCP, GLP, regulatory professionals.

Speaker

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.

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