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Validity : 02nd May'25 to 12th May'25
Laboratory Investigation of Out-of-Specification (OOS) Results
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.
Overview of the webinar
Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that are out-of-specification or outside of statistically expected ranges.
Who should attend?
- Laboratory Managers
- Laboratory Supervisors
- Laboratory Analysts
- Quality Assurance Managers
- Quality Assurance Record Reviewers
Why should you attend?
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.
Faculty - Dr.Jerry Lanese
Jerry Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry.