2-day In-person Seminar on Statistics for Quality Control and Assurance at New Jersy September 27, 2012

Overview: This course will describe the use and application of simple, basic statistical procedures, especially as they can be applied to the types of studies needed in the field of pharmaceutical quality systems. The course will focus on the use of statistical functions for the execution of validation studies, the setting of specifications and the on-going monitoring of manufacturing processes and analytical methods. Attention will also be given to checking employee performance and comparing actual test results to expected values.

The course will not require the use of any particular software or a computer. It is presented with a paper-and-pen approach so the attendee can understand that processes that must occur for the calculations to be made in a software package.

Why should you attend: Although there are many software packages for performing statistical calculations, the worker dealing with quality issues needs to understand the proper use and interpretation of statistical functions and procedures. Many mistakes have been made through the improper application of statistical functions and the misinterpretation of the results of statistical calculations. This course is aimed at providing the attendee with an understanding of how the calculations are to be done, under what circumstances they should be applied, and the meaning of their results. The worker who needs to apply statistical procedures and the supervisor who needs to be able to review and understand the results of statistical procedures at a basic level will benefit from attending this course.

Detailed Agenda:

Day 1, September 27, 2012

Course Modules & Content Details:

Lecture 1: Introduction to Process Statistics
Averages and variability
Standard deviations and the standard error of the mean.
Setting specifications using intervals
Confidence and tolerance intervals
Lecture 2: Comparing two sets of data.
t-Tests and the deviation about a mean.
Demonstrating that specifications are met.
Comparing deviations.
Sampling and replicates
Lecture 3: Comparing multiple sets of data.
One-way and two-way analysis of variance.
Duncan's multiple range test.
Latin square designs
Factorial designs
Lecture 4: Regression analysis
Linear regression
Linear correlation analysis
Day 2, September 28, 2012

Lecture 5: Screening methods and Factorial designs.
Plackett-Burman Method.
Studying an analytical method.
Process design study
Importance of confounding.
Lecture 6: Monitoring Methods and Processes
Process Capability Indicies
Statistical Process Control for variable data.
The Western Electric rules.
Lecture 7: Statistical Process Control for attribute data.
Dealing with counts.
CUSUM charts for single points.
Lecture 8: Other Procedures
Non-parametric tests when a normal distribution cannot be assumed.
The Wilcoxon Signed Rank Test.
The Poisson Distribution for infrequent events.
The Spearman-Karber Method for estimating counts.
Who Will Benefit:
Directors
Managers
Supervisors, and Lead Workers in Quality Control
Quality Assurance
Engineering, and Regulatory Affairs
Workers who will be participating in operations or the supervision of the development or manufacturing of pharmaceuticals should also attend this course.

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.