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Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market
When performing process validations the question frequently asked is “How many do I need?”
The answer is — it depends. There are several factors that must be considered when determining the appropriate sample size, including risks assessment, production costs, inspection costs, measuring, and testing.
If you’re like many manufacturers, you understand the essence of the 21 CFR 820.30 requirement — you must run enough test samples of a product so its test results can be successfully applied to full-scale production runs. (Also, your sample size must be appropriate for the type of testing you’re doing and the type of product.)
And, like many manufacturers, you’ve probably had trouble determining exactly how many units of a product you should test to satisfy the FDA.
Join design control statistical expert Steve Walfish as he helps you understand exactly what sample size depends on. During his presentation, you will learn:
You will also gain the fundamental knowledge you need 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:
You'll 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 your facility.
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.
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