Fundamental Tools in Statistics for GMP Compliance

Venue: Courtyard by Marriot at Jersey City Newport

Location: Jersey City, New Jersey, United States

Event Date/Time: Feb 02, 2010 End Date/Time: Feb 03, 2010
Registration Date: Feb 01, 2010
Early Registration Date: Dec 17, 2009
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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
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


540 Washington Boulevard
Jersey City
New Jersey
United States