Overview:  The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.This live webinar training will provide a clear process for compliant laboratory OOS investigations. Why should you Attend: The FDA is inspecti..

Overview:  
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

This live webinar training will provide a clear process for compliant laboratory OOS investigations.

Why should you Attend:
The FDA is inspecting laboratory operations very closely, with an emphasis on how the laboratory investigates Out-of-specification and out-of-tolerance observation investigations.

Areas Covered in the Session:
Why the regulators are concerned about the handling of OOS investigations.
The FDA model for handling OOS investigations.
Commonly accepted terminology such as repeat testing and retesting.
How the laboratory can meet regulatory expectations for OOS investigations.
The interaction between the laboratory and other units in the organization.

Who Will Benefit:
Laboratory Managers
Laboratory Supervisors
Laboratory Analysts
Quality Assurance Managers
Quality Assurance record reviewers

Speaker Profile:
Jerry Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

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