Today's FDA inspectors focus like lasers on device V&V testing methods — how they are justified statistically and the results. Join design control statistical expert Steve Walfish as he helps attendees understand exactly what it does depend on.

Falls Church, VA (PRWEB) October 30, 2015

Choosing the Best Device Sample Size for Verification and Validation:
Tools to Safely Speed Your Device to Market
**FDAnews Webinar**
Nov. 12, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/samplesize

Today's FDA inspectors focus like lasers on device V&V testing methods — how they are justified statistically and the results.

Manufacturers have had trouble for years determining exactly how many units of a product they should test to satisfy the FDA.

Mark the calendar for Thursday, Nov. 12, for access to Steve Walfish’s immensely popular webinar on sample size considerations.

Device manufacturers understand that they must answer the two key design verification and validation questions: did they make the product right and did they make the right product?

And testing is the only way to effectively answer them.

Finally, test samples must demonstrate that the results can be reasonably applied to larger production runs and maintain safety.

But how many units should manufacturers test? And when they decide, can they statistically justify that decision?

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These questions have baffled devicemakers for years. The answers are … well, it depends.

Join design control statistical expert Steve Walfish as he helps attendees understand exactly what it does depend on. During his presentation, attendees will learn:

  •     The requirements for statistical techniques and how they impact design controls processes (21 CFR 820.30(f)(g))
  •     What types of requirements lend themselves to statistics in verification and validation (hypothesis testing, confidence interval, design of experiments)
  •     How variance in the population can impact the sample size necessary to establish objective evidence
  •     The relationship between risk and sample size (i.e., risk to patient — critical major, minor)

Attendees will also gain the fundamental knowledge needed to determine sample size in statistical testing. (For example, a sample size of 3 is not sufficient without justification.)

In addition, Mr. Walfish will cover the following:

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  •     Why it is critical to understand the different compliance requirements for design verification and design validation — and how to understand those differences
  •     Leveraging statistical methods that work best to satisfy the FDA’s requirements for defensible methods
  •     How to use proven methodologies to avoid too small — or too large — sample sizes.
  •     How sample size should optimally be proportional to risk (business and patient)
  •     Why it’s pointless to try and predict the personal focus of different auditors — and why the real foundation for a successful audit is being able to produce a defensible program based on visible standards

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Attendees will learn proven tactics and tools to develop a strong statistical methods program — and a thorough understanding of what FDA auditors look for when they come for an inspection at a facility.

Meet the Presenter:
Steven Walfish is the president of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to a variety of industries. Prior to starting Statistical Outsourcing Services, he was the Senior Manager Biostatistics, Non-clinical, at Human Genome Sciences in Rockville, MD. Prior to joining HGS, he was a senior associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.

Mr. Walfish brings more than 18 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. He has held positions with Johnson & Johnson and Chiron Diagnostics where he worked with large data sets for monitoring process data.

Who Will Benefit:

  •     Validation and verification professionals
  •     Quality engineering
  •     Regulatory Affairs
  •     QA/QC
  •     Software development, programming, documentation, testing
  •     R&D
  •     Engineering
  •     Production
  •     Operations    

Conference Details:
Choosing the Best Device Sample Size for Verification and Validation:
Tools to Safely Speed Your Device to Market
**FDAnews Webinar**
Nov. 12, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/samplesize

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/samplesize
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/devicesamplesize/prweb13053577.htm