The use of Excel in FDA-regulated environments goes beyond typical data organization and analysis. It demands careful attention to meet GxP compliance and to prevent serious compliance issues. Recent incidents in 2023 involving pharmaceutical and medical device companies underscore the criticality of ensuring 21 CFR Part 11 compliance. From formula errors leading to inaccurate drug dosage calculations to unsecured and improperly maintained spreadsheets risking product compliance records, non-compliant Excel usage has significant ramifications. Furthermore, unreliable data collection in clinical trials due to non-compliant spreadsheets puts the safety and efficacy validation of studied drugs at risk.
With these practical examples in mind, join us for an enlightening webinar that seeks to decode the process of creating and validating GxP-compliant spreadsheet applications, aiming to bolster your Excel competency and avoid FDA scrutiny.
In this practical, hands-on session, we will walk you through the process of configuring Excel for audit trails, applying security features, verifying data entry, among other important steps. We aim to equip you with the knowledge and skills to validate your application with a streamlined approach and make Excel a versatile tool that caters to your unique needs in an FDA-regulated environment.
Our extensive webinar is crafted to enable you to construct GxP-compliant spreadsheet applications using Excel's built-in 21 CFR Part 11 features, and this without the need for programming macros. Along the way, you'll learn effective techniques to evade 483s and Warning Letters, cut down on validation time and costs, and boost compliance with reduced resource deployment.
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
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
- Cell protection
- Data entry checks
- Audit trail
- Data output formatting
- Fill-in-the-blank validation templates
- Step-by-step validation
Using the validated application
- Maintaining, upgrading, re-validation
- Test cases
How to turn on the audit trail
- How to view the audit trail
Why Should You Attend:
In 2023, companies faced serious consequences for non-compliance with FDA's regulations related to the use of Excel spreadsheets in a GxP regulated environment. Missteps such as formula errors, improper version control, and inadequate data security can have grave implications, including FDA rejection of drug applications, compromised product compliance records, and invalid clinical trial data.
This webinar will provide you with the knowledge and practical skills to navigate Excel in a FDA regulated environment, with a focus on creating GxP compliant spreadsheet applications. You'll learn to effectively utilize Excel's built-in 21 CFR Part 11 features, avoid compliance issues, and streamline the validation process. By attending, you can help your organization avoid costly mistakes and ensure compliance with FDA's stringent regulations.
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.
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 General Data Protection Regulation (GDPR), software validation, and computer system validation.
Mr. Nettleton 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.
Mr. Nettleton 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.