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Statistical Techniques for Process Validation

solutionMedical device companies are challenged to provide compelling and risk free products to the marketplace in a timely, low-cost manner. One overwhelming theme driven by the FDA is "Mitigation of Risk". What is the risk? How will you reduce or eliminate the risk? Is your approach logical? How will you document all of the above?

A subset of risk mitigation is process validation. A validated process is one that is virtually certain to produce product that meets requirements. Rigorous data collection, graphical and statistical analysis, and confirmation of results are fundatmental to modern validation efforts. In this seminar, you will learn about the key risk assessment and analysis tools used by industry and espoused by the GHTF for effective and efficient process validation.

Attend this two day seminar and learn how to successfully apply simple and intermediate statistical techniques to your process validation activities.

Cost: $1500.00

Call 1-719-282-1143 to Register.

Click on the tabs below for more information.

Agenda

  • Goals, outcomes, expectations
  • Brief overview of FDA guiding documents for Process Validation.
  • Linkage with GHTF guidelines
  • Overview of tools for Risk Assesment
    • FTA
    • Hazard Analysis
    • FMEA/FMECA
  • Some tools for mistake-proofing of designs and processes
  • Gathering reliable data.
    • Gage studies
    • Measurement System Analysis
    • Analysis of measurement systems for destructive, non-destructive, and attributes data.
  • Graphical analysis of data
    • Histograms
    • Dot plots
    • Run charts
    • Time series plots
    • Multi-Vari charts
  • Introduction to Experimental Design
    • Screening experiments
    • Modeling experiments
    • Robustness experiments
  • Process Control
    • Steps in setup of a process control system
    • Basics of a control chart
    • Control charts for attributes and variables data
    • Cp, Cpk
  • Group exercises.

 

Trainer

Robert Launsby has taught thousands of students Statistical techniques and hundreds in the area of Six Sigma. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.

Dates/Locations

The dates and locations are listed below:

Location Date
Colorado Springs, CO July 12 & 13, 2012
Colorado Springs, CO September 20 & 21, 2012

Cost

Fees: $1500 includes the book Engineering Today's Designed Experiments, Participant Guide and a 45 day trial version of DOE Wisdom software. Lunch and coffee breaks are provided each day.

Guarantee

Launsby Consulting seminars and products are fully guaranteed. If any of our seminars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.

Refund Policy

When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee

 

Register Early - class sizes are limited for optimal interaction and instruction.

Call 1-719-282-1143 to Register.

If you have any questions, please feel free to email us at or call us at 1-719-282-1143.

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