If you're looking for a comprehensive overview of fundamentals regarding statistics in validation, this IVT Network Special Edition is the perfect.
Statistics in Validation is a compilation of 13 of our most robust, peer-reviewed papers by renowned validation statisticians. From "Understanding and Reducing Analytical Error—Why Good Science Requires Operational Excellence" and "Improvement Alphabet: QbD, PAT, LSS, DOE, SPC - How do They Fit Together?" to "Statistical Considerations for Design and Analysis of Bridging Studies" and "FDA, Globalization, and Statistical Process Validation," they'll help you uncover best practices for your experiments.
Take a deep dive into process validation from a statistical viewpoint, explore design of experiments (DOE), and read illuminating case studies from industry leaders.
Such authors include award-winning compliance expert Kevin O'Donnell from the European Medicines Agency, and one of IVT's most-read authors, Eugenie Khlebnikova of McNeil Consumer Healthcare.