Out-of-Specification (OOS) Result Investigation

Charity Ogunsanya

Course description

How to Perform a Compliant, Effective, and In-depth Out of Specification (OOS) Investigation

Some FDA (form 483s) and other regulatory bodies inspectional findings, FDA warning letters, product recalls and plant shutdown (voluntary or involuntary) sometimes relate to incomplete, ineffective, and non-compliant OOS investigations that impact a manufactured product. Per the regulations, all Failures, Deviations, or OOS results investigations regardless of its product impact should be appropriately documented, investigated, and analyzed for the root cause(s), with a justifiable retest plan and an effective corrective action plan. Understanding how to identify a true OOS from other types of Laboratory investigations, Invalid Assays, Known Lab Error, Atypical Events, or Lab Calibration out of Tolerance as well as when to perform a retest based on the findings of the OOS investigation is critical to achieving compliance. It is also critical to know when and how to apply averaging versus an outlier to an original test and re-test data generated during an OOS result. This will allow a product manufacturer to achieve compliance relating to an OOS investigational process.

This accredited training will benefit manufacturers of cGMP products in designing an effective, robust and compliant OOS investigation process.

Upon completion of this course, you will be able to:

• Apply the regulatory guidance and differentiate between a true OOS, a Known Lab Error (KLE), an Atypical Event (ATE), and a
  Laboratory Calibration Out‐of‐Tolerances(LCOT investigations)
• List the Attributes of a Full‐Scale OOS Test Result Investigation and the step‐by‐step process of how it is performed
• Describe when, how and the criteria to be applied when performing re‐sampling and retest of a product including handling inadequate re‐sampling Methodology
• Summarize how to report and interpret test results including the appropriate and inappropriate use of “Averaging of Test Data” or “Statistical Outlier Tests”
• Describe how to handle the interpretation and disposition of products for confirmed, unconfirmed or inconclusive OOS test result investigational findings
• Describe how to Process, conclude and approve an OOS Test Result Investigation including the Impacted Departments
• List the different ways of documenting an OOS investigation (Manual versus automated system) as well as the advantages and disadvantages of each documentation system