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