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Consulting is our commitment of support. Our statistical expertise spans all stages of development, from research, to validation, and to manufacture.Contact usfor a free initial consultation on any statistical, manufacturing, or compliance issue.

Areas of Expertise:

Statistics for non-Statisticians

Statistical implications of the CGMP�s

Statistical Thinking

Process Capability Studies

  • Cp, Cpk
  • Tolerance Intervals for natural limits
  • Control charts in a GMP environment
  • Statistical Process Control / Statistical Quality Control

Process Analytical Technology, PAT

  • Three phases of PAT
  • True Process Knowledge

Design of Experiments, DoE

  • DoE for PAT
  • Validation by Design®
  • �Quality by Design®
  • �Design Space�
  • Ruggedness and robustness
  • Factorials, fractional factorials
  • Plackett-Burman designs
  • Response Surface Methodology, RSM

Data Analysis

  • Statistical graphics
  • Regression and correlation
  • Outliers and aberrant values; SOPs
  • Significant digits and rounding rules

Bergum's Method for Content Uniformity

Out-of-Specification Results: FDA OOS Guidance

Trending and Out-of-Trend analysis, OOT

Sampling Plans

  • Square Root of (N)+1 plans
  • Reviewing sampling SOPs
  • ANSI/ASQ Z1.4 attribute plans
  • ANSI/ASQ Z1.9 variable plans
  • AQL = 0.00 for critical characteristics ?

ICH Q2: Analytical method validation

ICH Q6, Setting specifications; writing SOPs

  • X bar � 3S, friend or foe?
  • Distribution analysis of historical data
  • Statistical Tolerance Intervals

ICH Q8 Pharmaceutical Development

  • DoE for product and process development

ICH Q9 Quality Risk Assessment

Quality Philosophy, TQM, Six Sigma

  • Deming, Juran, Ishikawa, Taguchi

USP <1010> Analytical Data

ASTM E11 Statistics and ASTM E55 PAT

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