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- Get answers to your questions through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions. You can also type in your questions using Chat box in the meeting window.
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Recorded Session - How it works
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Training CD/ USB - How it works
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This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. It has a detailed presentation and live Excel demonstration followed by an interactive workshop. 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.
Who is the Target
- All Excel users
- Laboratory staff
- Develop spreadsheet applications
that are GxP compliant.
- Avoid 483s and warning letters.
- Understand what does and does
not need to be validated.
- 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
- Configure Excel for audit
trails, security features, data verification, and multiple concurrent users.
May, 11, 2018 - 21 CFR Part 11: How to validate software for SaaS/Cloud
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.