The Statistics of- Design Verification, Process Validation, and Statistical Process Control at SFO

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. His experience as an instructor in statistics includes having given 3-day workshop/seminars for the past several years at Ohlone College (San Jose CA), 1-day training workshops in SPC for Silicon Valley Polytechnic Institute (San Jose CA) for several years, several 3-day courses for ASQ Biomedical, numerous seminars at ASQ meetings and conferences, and half-day seminars for numerous private clients.

Location: SFO, CA        Date: August 6th & 7th, 2015        Time: 9 AM to 6 PM 
Venue: DoubleTree by Hilton Hotel San Francisco Airport

Venue Address: 835 Airport Blvd., Burlingame CA 94010-9949

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until June 15, Early Bird Price: $1,295.00

From June 16 to August 04, Regular Price: $1,495.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Registration Link - http://bit.ly/1DkWa5y