FDAnews Announces -- How to Address Medical Device Sample Size Issues: What Regulatory and Quality Professionals Absolutely Must Know Webinar, Nov. 5, 2019
FALLS CHURCH, Va., Oct. 21, 2019 /PRNewswire-PRWeb/ -- How to Address Medical Device Sample Size Issues What Regulatory and Quality Professionals Absolutely Must Know **An FDAnews Webinar** Tuesday, Nov. 5, 2019, 1:30-3:00 p.m. EST https://www.fdanews.com/addressmedicaldevice
What impact do statistical techniques have on the 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 attendees 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.
Webinar Details: How to Address Medical Device Sample Size Issues What Regulatory and Quality Professionals Absolutely Must Know **An FDAnews Webinar** Tuesday, Nov. 5, 2019, 1:30-3:00 p.m. EST https://www.fdanews.com/addressmedicaldevice
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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