Spreadsheet Validation: Tools and Techniques to Meet FDA Requirements

Held Sept. 30, 2008

“David is very knowledgeable on the subject and presented the material very well.”
Previous webinar participant

Webinar back by popular demand!

This webinar made such a difference that drug and device companies asked for another chance to train staff who use and validate spreadsheets. We decided to offer it again.

Updated, enhanced — you can see what steps and strategies top validation expert David Harrison recommends to help you "bulletproof" your compliance programs.

Spreadsheet validation can close the compliance gap before you face high-profile FDA warnings and high-stakes liabilities. Do you know how to implement validation on your own spreadsheets? How to make sure you're meeting FDA expectations? And how to turn that large spreadsheet inventory around with minimum effort and minimal resources?

You’ll watch as David shares examples, manipulates cells and provides tips and tricks to streamline your spreadsheet validation process.

Step by step, he’ll walk you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place. Plus, David will provide examples of third-party software features that improve security and audit trail capabilities within Microsoft Excel spreadsheets.

See firsthand how to develop a spreadsheet that closes the gaps the FDA is after!

Order today to listen in and discover:

  • Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns
  • Sources of FDA publications on spreadsheet use and validation
  • What spreadsheet gaps the FDA is targeting
  • Today's best practices and options for validating spreadsheets
  • How to choose an approach for efficient and repeatable validation
  • How to fit spreadsheet validation into your traditional QA and validation processes
  • How to generate spreadsheet specifications
  • What to include in spreadsheet qualifications
  • How to test spreadsheets and macros
  • How to plan, manage and resource an effective project

Plus, you’ll see examples of documentation contents and test scripts used during validation.

With recent FDA white papers stressing the need for spreadsheet validation, and new Form 483s and observations zeroing in on spreadsheets, this training is critical for anyone in the drug or device industry who oversees or uses spreadsheets for data collection, data processing or data reporting. The needs span all departments, including QA/QC, production, engineering and even finance. Must-attend positions include:

  • Auditors
  • Clinical QA/QC specialists
  • Clinical research associates
  • Compliance officers
  • Data management and statistics personnel
  • Financial accountants and auditors (SOX404)
  • Managers
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Study monitors
  • Study research coordinators
  • Validation specialists, scientists and engineers
  • AND any compliance professional who uses Microsoft Excel spreadsheets
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

David Harrison is a principal consultant with ABB Engineering Services who specializes in pharmaceutical compliance and validation. He is currently the product manager for the ABB Excel Validation Solution and is responsible for managing the company's product and support services worldwide. His previous roles at ABB were in the introduction and implementation of 21 CFR Part 11 and computerized system validation projects and initiatives for key blue-chip pharmaceutical clients. Prior to joining ABB, David worked in various quality assurance roles within the drug and biotech industry in both the UK and the U.S.

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