Spreadsheet ValidationTools and Techniques to Meet FDA Requirements

Held Dec. 11, 2012

Do your Microsoft Excel spreadsheets pass FDA muster?

Do you know the changes that will be made to Excel in 2013?

Would you like to learn a defined approach that can make your task simple and straightforward, saving you both time and money?

Order your CD and Transcript webinar presentation for a hands-on learning experience by a trusted spreadsheet validation expert.  Training is critical for anyone in the drug or device industry who oversees or uses spreadsheets for data collection, data processing or data reporting.

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What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he posts entries and manipulates cells ... ask why he does this instead of that ... and get feedback?

What if you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval?

Well, you can.

Spreadsheet validation expert David Harrison conducts a crash course in bulletproofing your Microsoft Excel spreadsheets.

The FDA advises that all spreadsheets should periodically be revalidated and a permanent record of all cell formulas be updated. Training is critical.  Plan for your entire team to listen in — you won’t want anyone to miss out on learning the best practices and available options for validating spreadsheets, including:

  • Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns
  • Spreadsheet "gaps" the FDA is targeting
  • 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
  • Sources of FDA publications on spreadsheet use and validation

Plus, you’ll learn about third-party software features that improve security and audit trail capabilities within Microsoft Excel spreadsheets ... and see examples of documentation contents and test scripts used during validation.

Step by step, Mr. Harrison will walk you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place.

Spreadsheet Validation is one of our most popular webinars. Don’t miss out on your chance to get the CD and transcript!  Past sessions drew hundreds of participants from across the country. Here’s what some said:

“I liked that the potential options for spreadsheet compliance were well explained and the additional information sources on spreadsheet validation were provided.”
- Marko Oblak, Lek Pharmaceuticals

“This was a concise presentation with quality information from experts.” 
- Barry Bowyer, Lenstec, Inc.

Spreadsheet validation can close the compliance gap before you face high-profile FDA warnings and high-stakes liabilities.

Order Your CD and Transcript Today

The need spans all departments, including QA/QC, production, engineering — even finance. Must-attend job titles 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
  • PLUS every 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 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, Mr. Harrison worked in various quality assurance roles within the drug and biotech industry in both the UK and the US.

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