How to Make Excel Part 11 Compliant

MS Excel--A Spreadsheet Application
What validation means in the context of a spreadsheet isn’t well defined, and which spreadsheets need to be validated depends on what you’re doing with them. Part 11 and the FDA’s actions with that rule have caused a lot of doubt, fear, and uncertainty.

Learning Objective
In this e-conference you will learn which Excel spreadsheets must be validated to Part 11 and how to do so when you need to.

Mr. Wimmer Will Cover
This presentation will address your options for different uses of spreadsheets and how to validate them when necessary. He will address:
[x] Common uses for Excel.
[x] Different categories of spreadsheets.
[x] Relevant regulations and history.
[x] Excel's lack of compliance features.
[x] Where we are today with respect to Part 11 and enforcement.
[x] Options available to address Excel's shortfalls.
[x] Applying those options to the different categories of spreadsheets.
[x] Managing the whole process.
[x] How to approach the issue if it's an emergency and you have no money, time, or resources.

You will receive
[x] PowerPoint Slides.
[x] An expert speaker.
[x] A chance for Q&A.
[x] CEUs & Certificate.
[x] Case studies and resources for reference.

Audience suitability
[x] Anyone who designs case report forms.
[x] Anyone who designs databases in MS Access.
[x] Regulatory professionals who must defend the compliance of databases.
[x] Quality professionals who may audit the database.
[x] Managers and staff who are responsible for providing valid data.
[x] Information technology professionals who with clinical research functions.

Presenter
Derek Wimmer has worked in the device and pharmaceutical industries since 1994, with experience ranging from early research through post-marketing studies. In 1999 he started Wimmer Systems Inc., developing and marketing DaCS 21CFR11 compliance software for Excel data management. Today he is President of Wimmer Clinical Consulting Services.

The purchase is $423 for OnDemand access and $473 itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.