Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Overview
which explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. David Nettleton will make you 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
Webinar Takeaways
- 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
- Validate your application with minimal documentation
- Understand what does and does not need to be validated.
- How to specify and test your application
- Avoid 483s and Warning Letters
- How to use cell and file protections
- Reduce validation time and costs
- Increase compliance while lowering resource needs
Who Will Benefit
- All Excel users
- IT
- QA
- QC
- Laboratory staff
- Managers
- Executives
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty David Nettleton
Owner, Computer System Validation and FDA Compliance consultant. 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.