Spreadsheet Validation Tools and Techniques to Meet FDA Requirements

Held Oct. 25, 2011

Do your Microsoft Excel spreadsheets pass FDA muster?

Sign up now for a hands-on learning experience by a spreadsheet validation expert. 

You’ll discover best practices, tips, tricks ... and much more.

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.

Mark your calendar for Tuesday, Oct. 25, when spreadsheet validation expert David Harrison conducts a crash course in bulletproofing your Microsoft Excel spreadsheets.

Plan to sign up your entire team — 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.

Like every FDAnews webinar, Spreadsheet Validation is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.

Of course, Mr. Harrison will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in spreadsheet validation deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

Spreadsheet Validation is one of our most popular webinars. Prior years’ sessions drew hundreds of participants from across the country. Here’s what some said:

“The presentation was well thought out and well executed.”
Scott Hettel, Nordex Inc.

“Speaker provided good presentation of the topic along with good examples and
a demonstration of the tools which can be utilized in the validation process.”
Robin Piazza, Director, Watermark Research Partners, Inc.

“He gave good information on the process — all of the who's, what's and why's.
This webinar was insightful and easy to follow.”
Christa Ford, Quality Assurance Manager, Sciona Inc.

“It is reassuring that our company approach to Excel workbook validation is in
line with a reputable source associated with the FDA.”
Eric Kanazawa, Quality Engineer, Cepheid

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

Make sure you're meeting FDA expectations — sign up today!

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 need spans all departments including QA/QC, production, engineering — even finance. Must-attend job titles include:
            Clinical QA/QC specialists
            Clinical research associates
            Compliance officers
            Data management and statistics personnel
            Financial accountants and auditors (SOX404)
            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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