Consulting
When your business requires an expert independent opinion we are ready to assist.
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
