FDAnews Announces — Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market Webinar, June 22, 2016

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Many manufacturers have had trouble for years determining exactly how many units of a product to test to satisfy the FDA. Join design control statistical expert Steve Walfish on June 22 as he helps manufacturers understand exactly what sample size depends on.

Choosing the Best Device Sample Size for Verification and Validation:
Tools to Safely Speed Your Device to Market
June 22, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/bestdevicesamplesizevv                

Today's FDA inspectors focus like lasers on device V&V testing methods … how to justify them statistically … and the results.

Manufacturers must answer the two key design verification and validation questions: was the product made right and was the right product made?

Testing is the only way to effectively answer them.

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

But how many units should be tested? And, can they be statistically justified?

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

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

  •     The requirements for statistical techniques and how they impact design control 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 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.

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.

Who Will Benefit:

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

Webinar Details:
Choosing the Best Device Sample Size for Verification and Validation:
Tools to Safely Speed Your Device to Market
June 22, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/bestdevicesamplesizevv                

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/bestdevicesamplesizevv        
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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