Spreadsheet Validation Kit

The FDAnews Spreadsheet Validation Compliance Kit

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10 - 9999
February 2014
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Do your Microsoft Excel spreadsheets pass FDA muster? Can they meet strict 21 CFR Part 11 standards?

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

Order this hands-on learning experience led 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.

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.

Let's be honest. Your business probably relies on Excel spreadsheets that were created by employees long departed and modified by others many, many times.

Now, if over time you’ve diligently monitored all your Excel spreadsheets, you have nothing to worry about.

But if you're like some companies, you rely on thousands — even tens of thousands — of Excel spreadsheets. Imagine monitoring all of them.

Yet, the FDA advises that all spreadsheets should periodically be re-validated and a permanent record of all cell formulas be updated. Training is critical for everyone. 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 address the FDA requirement that spreadsheets be validated per 21 CFR 210-211 and Part 820
  • 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 2014 compliant 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

That's why FDAnews has created The FDAnews Spreadsheet Validation Compliance Kit. It will help you:

  • Introduce your staff thoroughly to spreadsheet validation, and
  • Train them in the options they need to achieve optimal validation, so your company can become safely compliant — and keep those FDA inspectors at bay.

What will you find in The FDAnews Spreadsheet Validation Compliance Kit? An invaluable collection of consolidated material from the FDAnews training database, designed to help your employees become fully up-to-speed as quickly as possible. For one low price, you get:

  • FDAnews' best-selling spreadsheet validation report. Chapter by chapter, you'll have the critical information you need to get down to the real nitty gritty in training your staff.
  • A 90-minute CD recording of FDAnews' recent highly-rated spreadsheet validation webinar. You'll hear from a validation expert without having to leave your office.  Play it for a single employee or a group, whenever it's convenient for you – and your staff.
  • Two excellent white papers on spreadsheet design, verification and validation, and use and storage in single- and multiple-user environments. Written by the FDA’s own Dennis Cantellops, the quality assurance manager of the San Juan, Puerto Rico District FDA Office, these papers tell you exactly how the FDA handles its own spreadsheets, so you'll know what they expect you to do with yours.
  • An impressive 65-page presentation filled with helpful examples, tips and flowcharts. Plus, the key questions your staff should know to ask when developing a spreadsheet validation program.

Let's face it. Sending employees for training is time-consuming and expensive. And it's frustrating when an employee you’ve trained leaves you to go to work for a competitor — and you have to start all over again.

But with The FDAnews Spreadsheet Validation Compliance Kit, you can train your staff for significantly less money, right there in your own office.

Developed by a specialist in pharmaceutical compliance and validation, this FDAnews training kit will show you and your staff how to create a spreadsheet validation program that satisfies both business and regulatory requirements. Plus, you’ll learn basic concepts like determining what the FDA expects from your validation program and how to build validation into your existing QA operation.

With The FDAnews Spreadsheet Validation Compliance Kit, you'll soon have a trained staff of spreadsheet validation experts and be on the road to successful compliance — without any fear of receiving a warning letter or 483.

Order Your Copy Today!


Available Format

Complete Kit – $597

(Add $10 shipping and handling per kit for shipping to the US and Canada, or $35 per kit for shipping elsewhere. VA residents, please add 6 percent sales tax.)

Kit Includes

  • FDAnews' best-selling spreadsheet validation report.
  • A 90-minute CD recording of FDAnews' recent highly-rated spreadsheet validation webinar.
  • Two excellent white papers on spreadsheet design, verification and validation, and use and storage in single- and multiple-user environments.
  • An impressive 65-page presentation

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library – a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. Return the hard copy within 30 days (in resalable condition) to receive your refund (less shipping/handling).

  • Pharmaceutical plant managers
  • Device plant managers
  • IT managers
  • Software developers
  • Quality assurance managers
  • Process assurance managers
  • Purchasing managers
  • GMP managers
  • Laboratory workers
  • Data entry workers
  • Clinicians

Meet the Expert

David Harrison is a principal consultant with ABB Engineering Services and specializes in pharmaceutical compliance and validation. He is the product manager for the ABB Excel Validation Solution.

His previous roles at ABB included introduction and implementation of 21 CFR Part 11 and computerized system validation projects. Before joining ABB, Harrison worked in various quality assurance roles in the drug and biotech industry in the U.S. and UK.

Need Extra Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

Customer Service:
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Email:  customerservice@fdanews.com