Fundamental Tools in Statistics for GMP Compliance

<p><b>These two-day comprehensive hands on program will cover the following topics </b></p><br> <ul><li>Introduction and basic overview of Common Statistical Tools</li><li>Fundamental Tools in Statistics</li><li>Statistical Process Control - Pareto chart <ul><li>Control Charts</li><li>Trending analysis</li><li>Control chart diagnostics</li><li>Design a statistically sound sampling Plan</li></ul> </li><li>Outliers</li><li>Applying statistics to specification Setting</li><li>T-test (one-sample, two-sample and paired)</li><li>Tolerance intervals and confidence intervals</li><li>Capability analysis - Cp, Cpk, Pp and Ppk</li><li>Implementing Design of Experiments (DOE)</li><li>Regression analysis</li><li>Interpreting a normal probability plot</li><li>Comparing confidence interval of parameters to p-value</li><li>Method Validation ICH Q2R1 Accuracy, Linearity, and Precision</li><li>Variance components</li><li>Statistics&nbsp; for Annual Product Review (APR) and how to present data</li></ul>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.