Fundamental Tools in Statistics for GMP Compliance

Venue: Dorint Hotel Don Giovanni Prague (CZ)

Location: Prague, Czech Republic

Event Date/Time: May 10, 2010 End Date/Time: May 11, 2010
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Description

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

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