Validation Sampling Plans - Seminar on selecting sample size and acceptance criteria for validations.

Validation Sampling Plans (1-day seminar)

Instructor

Dr. Wayne A. Taylor

Course Objective

This one day course is designed to help you select sampling sizes and acceptance criteria of one time studies like process validation, design verification and testing of product for first human use. The course shows how to:

Justify the sampling size and acceptance criteria selected based on the claim that can be made by passing a sampling plan.
Select a variety of sampling plans, all of which allow this claim to be made.
Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation.

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.

What You Will Learn

How to determine what claims can be made when passing a sampling plan.
How to select a sampling plan to make a specific claim.
How to use different types of sampling plans including single, double and variables.
How to reduce the number of units tested using variables plans.
How to increase the chances of a good product/process passing a validation using double and variables plans.
How to write protocols to handle contingencies so to avoid deviations.
Practical considerations including selecting representative samples.

Intended Audience

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.

Course Outline

Overview
Single Sampling Plans
Claims - OC Curves, AQL and LTPD
Double Sampling Plans
Variables Sampling Plans (and Normal Tolerance Intervals)
Tables of Validation Plans
Selecting the Best Plan
Writing the Protocol

Course Materials

Participants receive course manual.

Schedule

Dates	Location	Contact Information
November 18, 2008	St. Paul, MN	Offered through Minnesota Section of ASQ. Register through Century College at (651) 779-3341. Further info. Register.
In house seminars	Available at your location	We can be reached at (847) 367-1032, Fax (847) 367-1037, or info@variation.com.