Laboratory Investigation of Out-of-Specification 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. The discussion will be based on the FDA guidance on handling OOS laboratory results.

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. 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. This training will build the foundation for the implementation of adequate procedures and provide a review of existing procedures and practices.

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 Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.