Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Overview:

The use of Excel in FDA-regulated environments extends beyond basic data organization and analysis, requiring meticulous attention to GxP compliance and avoiding severe compliance issues. In light of recent 2023 incidents involving pharmaceutical and medical device companies, highlighted by FDA's new guidelines, the criticality of ensuring 21 CFR Part 11 compliance has never been more evident. From real-world cases of formula errors leading to inaccurate drug dosage calculations to instances of unsecured and improperly maintained spreadsheets risking product compliance records, the consequences of non-compliant Excel usage are substantial. These lapses not only impact product quality but also endanger patient safety, as seen in unreliable data collection in clinical trials due to non-compliant spreadsheets.

Join us for an enlightening webinar that decodes the process of creating and validating GxP-compliant spreadsheet applications. We aim to enhance your Excel proficiency and safeguard against FDA scrutiny, drawing lessons from recent FDA observations such as data manipulation, incomplete record-keeping, and improper audit trails.

In this practical, hands-on session, we will guide you through configuring Excel for audit trails, applying security features, and verifying data entry, among other critical steps. Our goal is to empower you with the knowledge and skills to validate your application effectively and utilize Excel as a versatile tool in an FDA-regulated environment.

Our comprehensive webinar is designed to help you construct GxP-compliant spreadsheet applications using Excel's built-in 21 CFR Part 11 features, without programming macros. Along the way, you'll learn techniques to avoid 483s and Warning Letters, reduce validation time and costs, and enhance compliance with minimal resource use.

Areas covered during the session include:

• Developing GxP compliant spreadsheet applications
• Utilizing Excel's built-in 21 CFR Part 11 features
• Apply features required for GxP environments without programming macros.
• Configuring Excel for audit trails, security features, data verification, and multiple concurrent users
• Avoid 483s and Warning Letters
• Implementing cell and file protections
• Understanding the validation scope and minimizing documentation
• Understand what does and does not need to be validated.
• Specifying and testing your application
• Q&A

Learning Objectives:

Why are spreadsheets so popular?

• Spreadsheet overview
  
• What are they used for?

Why is compliance a problem?

• How is it different from a calculator?

Developing Part 11 applications

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

Validation

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

Using the validated application

• Maintaining, upgrading, re-validation

Examples

• Requirements
• Specifications
• Test cases

How to turn on the audit trail

• How to view the audit trail

Why Should You Attend:

In light of the FDA's updated guidelines, it's crucial for companies to rigorously comply with regulations related to the use of Excel spreadsheets in a GxP regulated environment. Recent case studies reveal significant missteps, such as formula errors, inadequate audit trails, and flawed data integrity, leading to severe consequences like FDA warning letters, rejection of drug applications, and compromised product compliance records.

This webinar equips you with essential knowledge and practical skills to adeptly navigate Excel in an FDA-regulated environment, focusing on creating GxP compliant spreadsheet applications. You'll learn to effectively employ Excel's built-in 21 CFR Part 11 features, circumvent compliance pitfalls, and streamline the validation process. By attending, you will gain the ability to help your organization avert costly errors, ensuring adherence to the FDA's stringent regulations and safeguarding data integrity in clinical trials and product compliance.

Don't miss our engaging Q&A segment where your queries take center stage. Our speaker dedicates ample time to clarify doubts, ensuring you leave with a comprehensive understanding of Excel's role in FDA compliance. It's your opportunity to delve deeper into complex topics and receive personalized guidance. Join us for a session as informative as it is interactive.

Who Should Attend:

This webinar is designed for professionals who regularly use Excel in GxP regulated environments, such as:

• Quality Assurance and Quality Control Managers
• Data Management and Statistics Professionals
• Regulatory Affairs Professionals
• Compliance Officers
• Laboratory Managers
• Validation Specialists
• IT Professionals in the Pharma, Biotech, and Medical Device Industries
• Clinical Data Managers and Scientists
• Analytical Scientists
• Any professional keen on enhancing their Excel competency and understanding of its use in an FDA-regulated environment.

Whether you're responsible for creating or validating spreadsheet applications, managing product compliance, or overseeing data management in clinical trials, this webinar can enhance your proficiency and ensure your work aligns with FDA regulations.