Event Detail
Fundamental Tools in Statistics for GMP Compliance
February 2 - 3, 2010
- Jersey City NJ UNITED STATES
International Pharmaceutical Academy
These two-day comprehensive hands on program will cover the following topics: Introduction and basic overview of Common Statistical Tools Fundamental Tools in Statistics Statistical Process Control - Pareto chart Control Charts Trending analysis Control chart diagnostics Design a statistically sound sampling Plan Outliers Applying statistics to specification Setting T-test (one-sample, two-sample and paired) Tolerance intervals and confidence intervals Capability analysis - Cp, Cpk, Pp and Ppk Implementing Design of Experiments (DOE) Regression analysis Interpreting a normal probability plot Comparing confidence interval of parameters to p-value Method Validation – ICH Q2R1 – Accuracy, Linearity, and Precision Variance components Statistics for Annual Product Review (APR) and how to present data Case Study Sessions: Participants will be divided into groups of 4 to work on each case study and they will lead the discussion on the “report out” for each case study. CASE STUDY (1): Interpreting data and calculating summary statistics CASE STUDY (2): Setting Specifications and what would be the best approach? CASE STUDY (3): “Bake a Cake” - Using DOE, make the best cake using a three factor model CASE STUDY (4): Using Excel to do Regression - Developing a simple linear model and checking for residual patterns. CASE STUDY (5): Determining the accuracy and linearity of the assay by providing a data set. CASE STUDY (5): Reviewing Control charts - Setting up a control chart from a data set and determining if the process is in control. CASE STUDY (6): Developing Sampling Plans