Investigation of Out-Of-Specification Laboratory Results

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.

Why should you Attend:
All Laboratory and Quality Assurance management, analysts and reviewers should be aware of the FDA expectations for procedures that define a complete, scientifically sound investigation of each out-of-specification and out-of-trend laboratory observation and evidence that laboratory personnel are following the procedures.

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:
John (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.

Others Details

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