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Out of Specification Results (OOS) A One Day Workshop

Out of Specification Results (OOS) A One Day Workshop. Presented by: Karen S. Ginsbury PCI Pharmaceutical Consulting Israel Ltd. For IFF March 2007. Purpose of Workshop. Understand Current Industry Practice as it relates to all aspects of handling: Out of Specification Unusual

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3.21k views • 82 slides

A Statistical Approach to Method Validation and Out of Specification Data

A Statistical Approach to Method Validation and Out of Specification Data. Outline of talk. Basic statistics Averaging, confidence intervals Fitness-for-purpose and analytical capability. Quantifying variability and producing a capable method. Out-of-specification results. Conclusions.

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425 views • 23 slides

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Oos results - PowerPoint PPT Presentation

Out of Specification Results (OOS) A One Day Workshop

A Statistical Approach to Method Validation and Out of Specification Data