Spreadsheet ValidationTools and Techniques to Meet FDA Requirements

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1 - 9999
1 - 9999
1 - 9999
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?

Sign up now 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.

Register now

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.

Join spreadsheet validation expert David Harrison as he 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 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.

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:

“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.

Register now!

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

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.

Register now!

Date: Dec. 17, 2012 – Jan. 4, 2013
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

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