Consulting

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