How to Address Medical Device Sample Size Issues – Webinar Recording/ Transcript
How to Address Medical Device Sample Size Issues: What Regulatory and Quality Professionals Absolutely Must Know
More 483s are being issued for violation of 21 CFR 820.200, statistical methods — most often for a lack of statistical justification for sampling plans.
That’s why it’s more important than ever to understand the requirements for statistical techniques and how they impact your design-control process.
You can address your sample size issues. Design control statistical expert Steve Walfish is here to explain how.
During this presentation, he will develop a framework for justification. You’ll come away with a set of tools to help demystify statistical sampling plans.
- Appreciate the nuanced interpretations of 820.250
- Recognize the differences between confidence and reliability in the sample size
- Address actual issues faced by medical device companies through case studies
- Understand the importance of how data is collected and how to justify the sample size
- Incorporate statistical assumptions, such as independence, as part of all sampling plans
- Grasp how variance in the opulation impacts the sample size necessary to establish objective evidence
Take control of your sample size issues! Learn how to use sound risk management techniques in combination with statistical methods and reduce sample sizes.