Description
This interactive webinar explains how to configure and validate a GxP-compliant spreadsheet application to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand how to validate your application with minimal documentation. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.
Areas Covered in the Session:-
- Develop spreadsheet applications that are GxP-compliant
- Learn how to use Excel’s built-in 21 CFR Part 11 features
- Apply features required for GxP environments without programming macros.
- Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users
- Avoid 483s and Warning Letters
- How to use cell and file protections
- Reduce validation time and costs
- Increase compliance while lowering resource needs
- Validate your application with minimal documentation
- Understand what does and does not need to be validated.
- How to specify and test your application.
Who Should Attend?
- All Excel users
- IT
- QA
- QC
- Laboratory staff
- Managers
- Executives.
Speaker: 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. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most 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.
After Registration:
Once you register, you’ll receive a confirmation email with your login credentials and access to downloadable presentation materials. These resources can also be shared with your team for internal training and reference.
System Requirements:
Internet: A stable internet connection of at least 1 MBPS is recommended for a smooth experience.
Audio: Use a working headset or speaker with a microphone for clear audio, especially during interactive sessions.
Session Cancellation Policy:
If a session must be cancelled or rescheduled, WebinarWaves will notify all registered participants via email no later than 24 hours before the scheduled start time.
Can’t Attend the Live Webinar?
No problem! WebinarWaves provides On-Demand access to many of our top healthcare webinars. Learn on your own schedule, anytime. For help accessing your session:
Toll-Free: +1 6204136968
Email: support@webinarwaves.com
Address: 304 S Jones Blvd #001 Las Vegas, NV 89107
What Attendees Are Saying:
“WebinarWaves’ session was packed with insights we immediately applied in our facility. The speaker was fantastic and addressed real-world challenges.”
– Samantha L., Director of Nursing, Skilled Nursing Facility
Seamless experience! The slides and handouts were clear and useful, and I was able to share them with our entire coding team.”
– Brian K., Coding Supervisor, Hospital Network
