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2-day In-person Seminar on
Statistics for Quality Control and Assurance
Course "Statistics for Quality Control and Assurance" has been
pre-approved by RAPS as eligible for up to 12 credits towards a
participant's RAC recertification upon full completion.
Date & Time:
September 27th and 28th 2012 8 AM to 5 PM EDT
Instructor: Steven S Steven S Kuwahara
Duration: 2 Days
Kuwahara Founder & Principal, GXP
Price : $1,295.00 (for one
Location: Courtyard New Jersey
Steven S. Kuwahara, Ph.D. is the
Register for 4 Participants to Get 1 Free Pass founder and Principal of GXP
BioTechnology LLC, a consulting firm
that works in the areas covered by
Overview: the GLP and GMP of drugs, biologics,
and nutraceuticals. Steve has over
This course will describe the use and application of simple, basic 30 years of experience in
statistical procedures, especially as they can be applied to the types supervising quality control
of studies needed in the field of pharmaceutical quality systems. The laboratories, including an animal
course will focus on the use of statistical functions for the execution testing facility, and in performing
of validation studies, the setting of specifications and the on-going GLP and GMP audits of internal and
monitoring of manufacturing processes and analytical methods. external testing laboratories . Steve
has participated in the development
Attention will also be given to checking employee performance and
of drugs and biologicals through all
comparing actual test results to expected values.
phases of clinical research and final
product production. ...more
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
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calculations to be made in a software package.
Your Necessity is our Priority
Day 1, September 27, 2012
Course Modules & Content Details:
Lecture 1: Introduction to Process Statistics
l Averages and variability
¡ Standard deviations and the standard error of the
l Setting specifications using intervals
¡ Confidence and tolerance intervals
Lecture 2: Comparing two sets of data.
l t-Tests and the deviation about a mean.
l Demonstrating that specifications are met.
l Comparing deviations.
l Sampling and replicates
Lecture 3: Comparing multiple sets of data.
l One-way and two-way analysis of variance.
l Duncan's multiple range test.
l Latin square designs
l Factorial designs
Lecture 4: Regression analysis
l Linear regression
l Linear correlation analysis
Day 2, September 28, 2012
Lecture 5: Screening methods and Factorial designs.
l Plackett-Burman Method.
¡ Studying an analytical method.
¡ Process design study
¡ Importance of confounding.
Lecture 6: Monitoring Methods and Processes
l Process Capability Indicies
l Statistical Process Control for variable data.
¡ The Western Electric rules.
Lecture 7: Statistical Process Control for attribute data.
l Dealing with counts.
l CUSUM charts for single points.
Lecture 8: Other Procedures
l Non-parametric tests when a normal distribution cannot be
¡ The Wilcoxon Signed Rank Test.
l The Poisson Distribution for infrequent events.
l The Spearman-Karber Method for estimating counts.
Click here to register for this seminar
Who Will Benefit:
l Supervisors, and Lead Workers in Quality Control
l Quality Assurance
l Engineering, and Regulatory Affairs
l Workers who will be participating in operations or the
supervision of the development or manufacturing of
pharmaceuticals should also attend this course.
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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