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Marion Chatfield

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Articles

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Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

September 15, 2019

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach

April 02, 2010

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

FMEA tool

October 11, 2007

This downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.

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