How to Configure and Validate GxP Compliant Excel Spreadsheets

WEBINAR OVERVIEW:

This course trains attendees in best practices for creating GxP-compliant spreadsheets using Microsoft Excel. Attendees will learn how to validate applications with minimal documentation.

The instructor will provide step-by-step instructions for configuring Excel to include audit trails, security features, and data-entry verification. Participants will also engage in an interactive workshop to master essential techniques for using Excel spreadsheets for GxP data.

We advise you to bring your laptop to this session and use Excel to gain a complete and guided understanding of developing a GxP-compliant spreadsheet.

During the Q&A, the presenter will address your specific questions, discuss challenging scenarios for each participant, and provide detailed answers.

COURSE OBJECTIVES:

Upon completion of this session, attendees will learn how to:

• Avoid 483s and Warning Letters
• Ensure compliance with 21 CFR Part 11 when using Excel spreadsheets for GxP data
• Use cell and file protections
• Use Excel’s audit trail
• Reduce validation time and costs
• Increase compliance while lowering resource needs
• Understand what validation documentation is required
• Address issues and challenges specific to your projects.

AREAS COVERED:

1. Why are spreadsheets so popular?

• Spreadsheet overview
• What are they used for?

2. Why is compliance a problem?

• How is it different from a calculator?

3. Developing Part 11 applications

• Security
• Versioning
• Cell protection
• Data entry checks
• Audit trail
• Data output formatting

4. Validation

• Fill-in-the-blank validation templates
• Step-by-step validation

5. Using the validated application

• Maintaining, upgrading, re-validation

6. Examples

• Requirements
• Specifications
• Test cases

7. How to turn on the audit trail

• How to view the audit trail

WHO WILL BENEFIT:

• All Excel users in FDA-regulated environments
• QA Department
• QC Department
• IT Department
• Laboratory staff
• Managers and Executives
• Regulatory Affairs
• Documentation and Validation Specialists

ABOUT THE INSTRUCTOR:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, 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. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

David has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

REFUND POLICY:

Attendees may cancel their registration up to 24 hours before the course start time, and a full refund will be processed within two business days.

If a participant cannot attend the live session on a given date, they may request slots in the next schedule as an alternative.

Webinars may be canceled due to insufficient enrollment or unforeseen circumstances. In such cases, attendees will be notified at least 24 hours in advance, and a full refund will be issued.

For any questions or concerns regarding the webinar, please contact us at [email protected].

Event Venue

Online