Statistical Methods for Design Verification, Process Validation, and Process Control

Date	Sep 19, 2018
Time	11:00 AM EDT
Cost	$87249.50
Online

This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The entire 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that can also help improve product quality.

Areas Covered in the Session :

• FDA, ISO 9001/13485, and MDD requirements
• Statistically valid rationales for sample sizes
• The interpretation of statistical significance and statistical non-significance
• The impact of normality and non-normality
• Tests of Normality
• Transformations to Normality
• Concepts of “Confidence” and “Reliability” (a.k.a., %-in-specification)
• Concepts of “Quality” and “Variability” and “Process”
• Risk management

Who Should Attend :

• QA/QC Supervisors
• Process Engineers
• Manufacturing Engineers
• QC/QC Technicians
• Manufacturing Technicians
• R&D Engineers