Investigating Out of Specification (OOS) test results is crucial to ensure pharmaceutical product safety and quality. The main objective is to identify the root cause of the OOS result. The QC/Analytical community is generally familiar with the FDA guidance on OOS investigation. However, there are some unique aspects of applying the guidance to biotech products. We will discuss three topics in this session.
We have invited three industry experts as panelists to share their success stories and challenges, followed by roundtable discussions.
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