Overview:
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
- 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 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.