Dr. Wayne Taylor - Taylor Enterprises, Inc.
for Engineers and Quality in the FDA Regulated Industries
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Validation Sampling Plans (1-day)
This one day course is designed to help you select sampling sizes and acceptance criteria of one time studies like process validation, design verification, component qualifications and testing of product for first human use.
The course shows how to:
This course is task orientated in that it provides all the knowledge and tools required to accomplish the task of selecting samples sizes and acceptance criteria for one time studies. No prior knowledge or special background is required.
This course focuses on demonstrating the proportion nonconforming meets a defined level. Passing the sampling plans allows one to make a statement like with 95% confidence there is less than 1% nonconforming or equivalently with 95% confidence there is more than 99% conformance. Validation Sampling Plans II covers other statistical properties like rates, average, standard deviation, and relative standard deviation.
What You Will Learn
This course is designed for those individuals who select sampling plans for both validation and other one time studies and for those whose manage such activities. This includes engineers, manufacturing and quality supervisors, and management. No special statistical or mathematical background is required.
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Last modified: September 08, 2017