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In a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical manufacturing, Lynn Torbeck has created a "must-read" for anyone involved in product development, formulation, manufacturing and quality.
Each of the 45 chapters in this book addresses a specific aspect of applied statistics and provides pragmatic applications on such topics as:
- Can we save the Technical Conference?
- %RSD friend, Foe or Faux?
- OOS, OOT, OOC and OOSC
- Can AQLbe Zero?
- Outlier Management
- Why 5%?
- Design Space Circa 1987
- Quality by Design Circa 1982
- Training Scores
Because this book is not organized in a linear fashion, Torbeck encourages readers to dip into any chapter that is of interest. This book is not a statistics text per se; however, it shares the author's passion and decades of experience for statistics applied to pharmaceutical quality by showing how they can be used in real-world pharmaceutical quality problems.
About the Author
Lynn D. Torbeck, started Torbeck and Associates in 1988 providing training and consulting in applied statistics and experimental design for pharmaceutical and biopharmaceutical development, quality assurance and control. Specific effort was targeted to process and method validation under cGMPs. Publications include many journal articles, books and chapters. Specifically, Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab®, Validation by Design and Square Root of (N) Sampling Plans as well as a chapter in Pharmaceutical Quality titled Using Statistics to Measure and Improve Quality.