Firms developing devices for the market often have few statistical resources available – no staff dedicated to statistical analysis, too few personnel with time to develop an understanding of what is needed, and limited experience in the overall development of 510(k)s.
Most of the statistical analysis for a 510(k) can be accomplished using off-the-shelf software or Microsoft ExcelTM. But while this software may look like a quick and attractive solution, non-statisticians still find themselves confronted with interpreting the results of their analysis without sufficient training. This can lead to unnecessary and avoidable confusion and mix-ups in the reporting of results to FDA.
If you're facing putting together a 510(k), familiarize yourself with the most common (and daunting) issues -- and what you shouldn't do in your statistical analysis. Don't jeopardize your substantial equivalence success with a simple and easily avoidable error.
On Tuesday, May 4. join FOI Services and Steven Walfish at 1:00pm EDT for a 90-minute teleconference to examine the top ten statistical mix-ups and how to avoid them. If you’re an experienced statistician, this presentation isn’t for you – but if you’re a statistical beginner, you’ll appreciate the practical advice that will help you put together a statistically sound 510(k).
Note: This presentation is NOT intended for experienced statisticians.
Steven Walfish is the President of Statistical Outsourcing Services, a consulting company providing statistical analysis and training to FDA-regulated industry. Prior to starting this firm he was the Senior Manager -Biostatistics, Non-clinical at Human Genome Sciences, a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry, and Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex statistical problems including data collection, analysis and reporting.
Mr. Walfish has been an invited lecturer at many industry meetings, and is also a regular contributor to journals serving FDA-regulated firms. For additional information on his background, visit his website at www.statisticaloutsourcingservices.com
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout approximately 1-2 days before the teleconference. The materials may be duplicated for anyone attending.
Tuesday, May 4, 2010; 1:00pm – 2:30pm EDT (GMT -4)
In your office or conference room
To register online, or for details on additional upcoming teleconferences, go to www.foiservices.com/tc. You may also call 1-800-654-1147 (outside the U.S. and Canada call +1-301-975-9400) to register by phone.