Configuring and Validating GxP Compliant Excel Spreadsheets

Course overview:

This course trains attendees in best practices for creating GxP-compliant GAMP category 4 and 5 MS Excel spreadsheets. 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.

You'll also engage in a guided, practical workshop to master essential techniques in MS Excel to ensure your spreadsheets process GMP data accurately and reproducibly so that your decisions do not adversely affect the patient’s health.

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

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:

• Validation processes that include developing functional requirements, creating the spreadsheet, and conducting thorough qualification testing
• Essential tests during validation for verifying calculations, logical functions, data handling under extreme conditions, performance with large datasets, error handling, and integration with external systems
• Controlling access, training users, and storing records appropriately to maintain the integrity of validated spreadsheets
• Performing root cause analysis in case the tests reveal issues, implementing corrective actions, and updating the validation protocol as needed.

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

Why should you attend?

FDA-regulated/ GMP facilities use Excel spreadsheets developed with formulas, macros, and many other functions.

These spreadsheets process the raw data entered and generate useful information. Staff at GMP facilities rely on the accuracy of that information to decide whether to accept or reject a pharmaceutical batch. Hence, you need to ensure that those Excel spreadsheets are processing GMP data accurately and reproducibly so that your decisions do not adversely affect the patient’s health.

This webinar will provide a practical framework and approach for the Excel spreadsheet validation used in direct or indirect GMP-related activities, empowering you in your decision-making process. We will show how to validate Excel spreadsheets designed and used for decision-making in GMP environments, which directly impact product quality, safety, and identity of medicinal products.

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 care@thecomplyguide.com.