Special Edition

Statistics in Validation

If you are looking for a comprehensive overview of fundamentals regarding statistics in validation, this IVT Network Special Edition is perfect for you. Statistics in Validation is a compilation of 13 of our most robust peer reviewed papers by some of the most reknown validation statisticians, to help you uncover best practices for your experiments.
In this Edition, you will take a deep dive into proceess validation with a statistical viewpoint, explore design of experiemnts (DOE), and read about illumninating case studies from industry experts. Such authors include award-winning Kevin O'Donnell from the European Medicines Agency, and one of IVT's most-read authors, Eugenie Khlebnikova of McNeil Consumer Healthcare.

A complete overview is below.

Table of Contents

Risk Analysis and Design of Experiments in Process Validation Stage 1
Kevin O'Donnell

First Steps in Experimental Design II: More on Screening Experiments
John A. Wass

A Further Step in Experimental Design (III): The Response Surface
John A. Wass

Linear Regression 101
Yanhui Hu

Linear Regression 102: Stability Shelf Life Estimation Using Analysis of Covariance
David LeBlond, Daniel Griffith, and Kelly Aubuchon

Understanding and Reducing Analytical Error—Why Good Science Requires Operational Excellence
John McConnell, Brian K. Nunnally, and Bernard McGarvey

Analysis and Control of Variation: Using Process Control to Reduce Variability: Comparison of Engineering Process Control with Statistical Process Control
John McConnell, Brian K. Nunnally, and Bernard McGarvey

Improvement Alphabet: QbD, PAT, LSS, DOE, SPC - How do They Fit Together?
Ronald D. Snee

Statistical Analysis in Analytical Method Validation
Eugenie Webster (Khlebnikova)

Statistical Tools for Development and Control of Pharmaceutical Process: Statistics in the FDA Process Validation Guidance
Paul L. Pluta

Statistical Considerations for Design and Analysis of Bridging Studies
Harry Yang and Timothy Shofield

FDA, Globalization, and Statistical Process Validation
Robert L. Creighton and Marlene Garcia Swider

Statistical Sampling Plan for Design Verification and Validation of Medical Devices
Liem Ferryanto

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