Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Recorded Webinar | David Nettleton | From: Dec 02, 2021 - To: Dec 31, 2021

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Recording
   $99  
DVD
   $109  
Recording + DVD
   $209  
Transcript (Pdf)
   $99  
Recording & Transcript (Pdf)
   $199  
DVD & Transcript (Pdf)
   $209  


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Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

Areas Covered in the Webinar:-

  • Avoid 483s and Warning Letters.
  • Ensure compliance with 21 CFR Part 11 when using Excel spreadsheets for GxP data.
  • How to use cell and file protections.
  • How to use Excel’s audit trail.
  • Reduce validation time and costs.
  • Increase compliance while lowering resource needs.
  • Understand what validation documentation is required.
  • Hands-on workshop to address your specific needs.

Why Should You Attend:-

This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data.

Who Should Attend:-

This session will benefit for:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives

David Nettleton

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.