Spreadsheet Validation
Tools and Techniques to Meet FDA Requirements

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 tips and tricks that help streamline your spreadsheet validation process for quick-and-final FDA approval?

Well, you can.

When spreadsheet-validation demon David Harrison conducts a crash course in bulletproofing your Microsoft Excel spreadsheets. Sign up your entire team! You’ll discover best practices and 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 walks you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place.

You follow along on your own screen without ever leaving the convenience of your office. No need to ferry staff halfway across the country at a cost of tens of thousands of dollars, not to mention precious days away from the office. Now the internet makes such interactive seminars possible.

It’s a repeat of a sellout! Last year’s conference drew dozens of participants from across the country. Here’s what some said:

“Speaker demonstrated a good understanding of the subject matter. The validationdecision point was good and the sample spreadsheet with the day/time, version and signature page was very helpful.”
– Laura Jacoby, QA Associate II, Kimberly-Clark

“Format of the presentation worked well and was a good use of our resources. The information presented was timely and pertinent to our process. The resources for additional reading are useful as well.”
– Maureen French, QA Supervisor, McGuff Pharmaceuticals

”Content dealt directly with issues of compliance and validation of data collection and manipulation applications in use across our corporation and by our suppliers. My compliance staff can use the information presented to better assess the compliance of those systems.”
– Douglas Hunt, Director, Corporate Quality Compliance, Genzyme Corporation

”Brought to light things I had not previously considered such as the validity of spreadsheets attached to test reports containing validation data.”
– Lisa King, Supervisor-Document Services, CarboMedics

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!