Online Webinar 2019 - Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance
Topics/Call fo Papers
Overview
This interactive webinar 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. 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
Session Highlights.
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
speaker:
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR 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 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
This interactive webinar 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. 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
Session Highlights.
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
speaker:
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR 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 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
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Last modified: 2019-04-04 20:11:37