Determining a Statistically Valid Sample Size: What Does FDA Expect to See?

Presented by Steven Walfish
Wednesday, March 28, 2018; 1:00pm - 2:30pm EDT (GMT -4)

What, exactly, does FDA expect you to do to justify how you’ve determined sample sizes that appropriately support your device submission? 21 CFR 820.250 - Statistical Techniques has just two clauses that focus on the establishment and maintenance of valid procedures…and there’s no guidance to help you interpret those requirements.

The result? The onus is on YOU to demonstrate sound, valid statistical practices.

On Wednesday, March 28 at 1:00pm EDT, join FOI as Steven Walfish, Principal Science & Standards Liaison, USP, will present a 90-minute audio-format teleconference to examine the techniques commonly and successfully used to determine and set appropriate sample sizes. Combining a basic introduction to how statistics are used in determining sample size with examples of common mistakes, this session will give you practical approaches, background, guidance…and confidence. It will also address when novices can effectively do the needed statistics using Excel or other off-the-shelf software, as well as how to recognize when you’re in over your head and need to bring in an experienced statistician.

Everyone with a responsible role in developing a device submission should be familiar with the statistical methods used and the data required to determine an appropriate sample size. No previous statistical analysis experience is needed to benefit from this presentation – just a desire to learn. (If you’re a statistician, encourage colleagues from other departments to sign up – to make it easier for everyone to understand the data you need and the rationale underlying your analyses.)

The Presentation Will Cover:

What You'll Get:

Who Should Attend:

This presentation is intended for non-statisticians in the device and combination products industries, especially those contributing to FDA submissions, including:

About Your Instructor:

Steven Walfish is President of Statistical Outsourcing Services, a consulting company which provides statistical analysis and training to FDA-regulated firms, as well as serving as Principal Science & Standards Liaison at USP. Prior to starting Statistical Outsourcing Services, Steven 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. This variety of experience all contributes to decades of expertise in the development and application of statistical methods for solving complex issues including data collection, analysis and reporting.

Steven has been an invited lecturer at many industry educational meetings, an editorial board member for BioPharm International and a regular contributor to the professional literature. For more information about his background, or to inquire about the coverage of this teleconference, please contact him via his website at


In your office, conference room – or anywhere else you are!


Wednesday, March 28, 2018; 1:00pm to 2:30pm EDT (GMT -4)

Registration Options:

You can register for any of these options below. If you have questions or prefer to register by phone, call us at +1-301-975-9400.

Standard Order...Listen Live!

Your first toll-free (even if international) dial-in is $449 and covers one telephone connection – put the teleconference on your speakerphone and let everyone present listen for one price!

FOI Services will provide handouts and dial-in information for each connection ordered 1-2 business days before the teleconference.

Add extra connections to your Standard Order for only $89/line! Now you can affordably let colleagues in scattered offices, at home, on the road, or anywhere else listen live, too! When you place your Standard Order for a teleconference at the regular $449 price, you now have the option of adding more lines to the same invoice for only $89 per connection – just follow the directions online or call us at +1-301-975-9400! (Note: To qualify for this discount, extra lines must be ordered at the same time as a Standard Order.)

Can’t attend? Try the Audio Package for $449. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts. (Please allow one week after the event date for delivery.)

Listen Live..AND get a 50% discount on the Audio Package! If you order a live registration and the Audio Package for the same teleconference, you’ll receive a 50% discount on the audio. To order both the live registration and the audio package, register below, and you will be given an opportunity to add the audio as well. Or if you prefer, you can always phone FOI at 1-800-654-1147 (outside the U.S. and Canada call +1-301-975-9400).

Registration has closed.