Inadequate Investigation of Out-of-Specification (OOS) results is a common reason for laboratories receiving FDA 483s and Warning Letters. There is a growing concern that companies and laboratories are not applying good science in the investigation of OOS lab test results or tests that are outside statistically expected ranges. The level of OOS observations that are invalidated due to laboratory error will be very visible when the FDA starts collecting OOS test information through the proposed Quality Metrics program.
Join this session by expert speaker Jerry Lanese 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. Jerry will go in-depth into the FDA guidance on handling OOS laboratory results. You’ll get a clear understanding of compliant laboratory OOS investigations after attending this audio conference.
Why Should You Attend:
Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.
There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.
Areas Covered in the Webinar:
Key Points in the Presentation:
You will also get answers to the following tough questions:
Who Should Attend
- Dr. David Lim
Dr. John G. (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...
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