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Why Life Science Manufacturers Do What They Do in Development, Formulation, Production and Quality: A History

By Lynn Torbeck

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Gov. Price: $152.00Member Price: $168.00Nonmember Price: $207.00
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Gov. Price: $152.00Member Price: $168.00Nonmember Price: $207.00
  • Description
  • Table of Contents
  • Author's Bio

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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.

Table of Contents:

    1. Quality by Design Circa 1982
    2. Rugged and Rebustness Using DOE
    3. Valid Sampling Plans
    4. Reportable Values FOR OOS
    5. Statistical Thinking
    6. Preventing the Practice of Testing into Compliance
    7. Six Tools for Common Cause Variability Reduction
    8. Sector Charts
    9. Design Space Circa 1987
    10. Ten Deadly Statistical Traps in Pharmaceutical Quality Control
    11. Process Consistency and Variability Reduction
    12. Statistical Implications of the CGMPs, A 30-Year Retrospective
    13. USP <1010> Appendix E
    14. Outlier Management
    15. Square Root of (N) +I Sampling Plans
    16. Can We Save the Technical Conference?
    17. %RSD: Friend, Foe or Faux?
    18. The Role of Statistical Significance Tests
    19. Bergum's Method Recognized
    20. Thoughts on Probability for Risk
    21. On the Verge of Significance: Why 5%
    22. On Numerical Evaluations
    23. 100% Visual Inspection Goes Viral
    24. Walk Like a Statistician
    25. Can AQL be Zero?
    26. Implementing the Tools of Process Quality
    27. Statistics in the Service of Quality
    28. Tools in Waiting: Is it Time for EVOP?
    29. Pitfalls in Statistics
    30. Data Culture
    31. Absence of a Data Culture: "We Sent You the Good Ones"
    32. Reducing Risk in Risk Management
    33. Reducing Biological Variation
    34. OOS, OOT, OOC and OOSC
    35. Deviation Data Summary Report
    36. Secrets to Variability Reduction
    37. Is ICH Q9 a Failed Document?
    38. Why XBar ± 3S is not a Universal Solution
    39. Representative Sampling
    40. Placket-Burman Designs
    41. A Review of ICH Q10 Pharmaceutical Quality System
    42. Process Capability Indices
    43. Compositing Samples
    44. Observations on USP-NF <905> Uniformity of Dosage Units
    45. Reading and Activities

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.

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