FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014

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? 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.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) August 18, 2014

Choosing the Best Device Sample Size for Verification and Validation:
Tools to Safely Speed Your Device to Market
**FDAnews On-Demand Webinar**
Aug. 27, 2014 ● Any Time at Your Convenience
[http://www.fdanews.com/OnDemandDeviceSampleSize

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

They want to make sure manufacturers are applying the right statistical tools and methods, and that they are using them correctly, in a proper way.

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 manufacturers know that 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 when manufacturers decide, can they statistically justify that decision?

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

And that's why, on Aug. 27, design control statistical expert Steve Walfish will lead an FDAnews On-Demand webinar to help devicemakers 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:

  • 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. (Too small and it might not be accurately determining risk; too large and devicemakers could be unnecessarily wasting time and money.)
  • 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

So, clear the calendar for Aug. 27, 2014. 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.

Please note; this webinar has been previously recorded and no questions will be taken during the presentation. Attendees may listen to the recording at their convenience on Aug. 27.

Meet Your 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 On-Demand Webinar**
Aug. 27, 2014 ● Any Time at Your Convenience
[http://www.fdanews.com/OnDemandDeviceSampleSize

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

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