Guide to Validation Sampling Plans

THIS BOOK IS NOT YET AVAILABLE AND DOES NOT HAVE A PUBLICATION DATE SET.

This book focuses on applications of acceptance sampling plans for one-time protocol studies including design verification, process validation and effectiveness checks.  These sampling plans make confidence statements like 95% confidence more than 99% of product is conforming to the requirement. Also 95% confidence the relative standard deviation is below 2%. It serves as a basic introduction to acceptance sampling intended for the practitioner. It avoids complex mathematical formulas. Instead, it includes extensive tables.

It will cover the content of the 1-day course Validation Sampling Plans.

It explains the following procedures from the book Statistical Procedures for the Medical Device Industry:

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