Overview:
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. 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
- Avoid 483s and warning letters. Critical data, such as laboratory information and other GxP data, is often recorded in spreadsheet applications and are subject to regulatory inspection
- Learn how to use Excel's built in 21 CFR Part 11 features
- Apply features required for GxP environments without programming macros
- Validate your application with minimal documentation
- Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users
Speaker
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.Who Should Attend
- All Excel Users
- IT
- QA
- QC
- Laboratory Staff
- Managers
- Executives
