FALLS CHURCH, Va. (PRWEB) July 01, 2020
What impact do statistical techniques have on design control process?
How can one best address sample size issues?
Design control statistical expert Steve Walfish is here with a set of tools to help attendees understand statistical sampling plans.
Mr. Walfish will develop a framework for statistical justification where one will:
- Appreciate the nuanced interpretations of 21 CFR 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 population impacts the sample size necessary to establish objective evidence
Take control of sample size issues! Learn how to use sound risk management techniques in combination with statistical methods and reduce sample sizes.
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
How to Address Medical Device Sample Size Issues:
What Regulatory and Quality Professionals Absolutely Must Know
An FDAnews Webinar
Wednesday, July 15, 2020, 1:30-3:00 p.m. EDT
$287 per site
Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600
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