Webinars>>FDA Compliance>>GMP and GLP
FDA Rules for Investigating Out-of-Specification (OOS) Test Results
One of the most common observations cited in the FDA 483s and warning letters is inadequate investigation of out-of-specification results in GCLP or GMP laboratories. The OOS could be in a test results for a clinical assay or for an analytical release assay. Either way, the OOS must be investigated in a way compliant with the applicable FDA regulations. OOS investigations are also linked to the repeat assays and residual testing. A lot of confusion surrounds the FDA expectation regarding handling and investigation of an out-of-specification result and to deal with FDA audit findings.
This webinar will help you understand how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The focus will be on the FDA guidance and suggestions for a process that will meet the FDA expectations.
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