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Using Statistical Methods for Effective Outlier Detection Webinar by GlobalCompliancePanel

9/11/2013 10:00 AM - 11:00 AM

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

Dixon Test

Graphical methods to determine outliers

Who Will Benefit:

Management

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.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1afRm8B

Learn More: Using Statistical Methods for Effective Outlier Detection Webinar by GlobalCompliancePanel

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