Using Statistical Methods for Effective Outlier Detection Webinar by GlobalCompliancePanel
Overview: Statistical outlier detection has become a popular topic as a result of the US Food and Drug Administration's out of specification (OOS) guidance and increasing emphasis on the OOS procedures of pharmaceutical companies.
When a test fails to meet its specifications, the initial response is to conduct a laboratory investigation to seek an assignable cause. As part of that investigation, an analyst looks for an observation in the data that could be classified as an outlier.
Areas Covered in the Session:
What is an outlier?
How to label an outlier
Extreme Studentized Deviate Test
Graphical methods to determine outliers
Who Will Benefit:
Research and Development
Regulatory Affairs personnel
Quality assurance/quality control personnel
Auditors and inspectors
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.
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