Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance

Instructor: David Nettleton
Product ID: 701582
  • 23
  • May 2018
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 75 Min

Live Online Training
May 23, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 75 Min

One Dial-in One Attendee
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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

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.

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.

Who Will Benefit:

This session will benefit for:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives
Instructor Profile:
David Nettleton

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

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 260 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

Product Reviews Write review

We are moving in the directions of becoming a GLP facility and are having issues on how to properly manage our spreadsheets. We definitely have a better idea on how to use Excel, but still have some kinks we need to work out. Excellent presentation. Great information, and very knowledgeable instructor!
- Ashutos Swain

I have seen a couple presentations on using excel, this is by far the best. Much better to walk through how to do it than dote on the regulations as I have seen in the past.
- Ashutos Swain

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