Excel Spreadsheets; everything you need to know to pass a Part 11 inspection


02-November, 2023 AT 01:00 PM EST | 10:00 AM PST | 12:00 PM CST

Duration 75 Minutes

WATCH THE VIDEO...Meet the Instructor and Learn More About this Course


1 RAC CREDITS


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RAPS - This course has been pre-approved by RAPS as eligible for up to 1 credits towards a participant's RAC recertification upon full completion.

Training Overview

Excel spreadsheet validation course will explain 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. Faculty 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
Faculty David Nettleton

David Nettleton (25 +yrs exp.)

Owner, Computer System Validation and FDA Compliance consultant

Sacramento, California Area

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 the development, purchase, installation, operation and maintenance of 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. 

1 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 1 credits towards a participant's RAC recertification upon full completion.


World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria