Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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

Can’t Make this LIVE Webinar?

Simply select the On Demand option when registering and we will send you access to the recorded version for 30 days. On Demand available within 3 business days after the live offering.

Our LIVE online training offers interactive participation. We highly encourage you to open your microphone and/or webcam during the live course to allow for the free exchange of remarks and questions between attendees and course director.