Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Steven Walfish

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

Areas Covered in the Session:
– How to collect a sample
– What are the two types of error (Type I and Type II)
– How to calculate sample sizes for variables data
– How to calculate sample sizes for attribute data
– Using confidence intervals on Cpk to calculate a sample size
– Using binomial confidence intervals

Who Will Benefit:
– Management
– Research and Development
– Regulatory Affairs Personnel
– Quality Assurance/Quality Control Personnel
– Auditors and Inspectors

Mr. Steven Walfish, MS is the Principal Science & Standards Liaison at United States Pharmacopeia (USP). Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.