The Statistics of: Design Verification, Process Validation, and Statistical Process Control - 2-day In-person Seminar
May 7 - 8, 2015 - Raleigh CA USGlobalCompliancepanel
support@globalcompliancepanel.com
Phone:8004479407
Fax: 302-288-6884
Overview: This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The 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 will also help improve the product. Why should you attend: All design and/or manufacturing companies perform design verification and/or process validation studies. A solid understanding of relevant statistical concepts and methods ensures that such efforts are efficient and accurate. In addition, all validated processes must be monitored to ensure their continued suitability (per the FDA). The statistical methods used for such activities are easily misused when their fundamental principles are not well understood. Mistakes in usage can lead to new products being launched that should have been kept in R&D; or, conversely, deciding to not launch a new product because of incorrectly calculated product reliability or process capability. Failure to monitor processes accurately can lead to a slow decline in product quality. This seminar provides a thorough, practical introduction to the relevant statistical methods that will help ensure quality results from R&D, Transfer, and Manufacturing. Areas Covered in the Session: FDA, ISO 9001/13485, and MDD requirements Statistically valid sample sizes The significance of statistical significance The impact of normality and non-normality Impact of risk analysis on choice of validation criteria Who Will Benefit: QA/QC Supervisor Process Engineer Manufacturing Engineer QC/QC Technician Manufacturing Technician R&D Engineer Agenda: Day One STATISTICAL ANALYSIS OF DESIGN VERIFICATION DATA AND PROCESS VALIDATION RESULTS Lecture 1: Regulatory requirements Lecture 2: Basic vocabulary and concepts Lecture 3: How to interpret Linear Regression Correlation coefficients Lecture 4: How to calculate confidence intervals (for proportions & for measurements) Lecture 5: How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations, and the concepts of "superiority" and "non-inferiority". Lecture 6: How to understand the output of an ANOVA calculation Lecture 7: Calculation of confidence and % in-specification (=reliability) for attribute data MTTF & MTBF (Mean time to Failure, and Mean time between Failure) normally-distributed variables data (including test for normality) non-normal data after transformation to normality non-normal data that cannot be transformed to normality Day Two: STATISTICAL PROCESS CONTROL (SPC) AND PROCESS CAPABILITY INDICES Lecture 1: What is Quality ? Lecture 2: Process Variation Lecture 3: What is Statistical Process Control ( SPC ) ? Lecture 4: Basic Types of Control Charts and how to construct them: XbarR, XbarS, XmR, P, and U. Lecture 5: Control Limits: Calculation & Re-calculation Lecture 6: Out of Control: How to Detect It, & What to Do if Detect It? Lecture 7: Sample Issues: Random, Sub-grouping, & Sample Size Lecture 8: Capability Indices and how to calculation them Lecture 9: Non-normal Data, and its impact on SPC. Lecture 10: How to Initiate & Implement a Successful SPC Program Speaker: John Zorich has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. Quick Contact: NetZealous BDA as GlobalCompliancePanel USA Phone:1-800-447-9407 Fax: 302-288-6884 support@globalcompliancepanel.com http://www.globalcompliancepanel.com