Dates: September 25 & 30, 2020 from 1:00 p.m. to 3:00 p.m. ET

  • Location: Virtual
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  • About the Series

    How do you know that you have quality if you cannot measure? 

    Test Method Validation (TMV) is not only an FDA regulatory requirement, it is key to quality and financial success. With successful implementation of TMV, you can minimize the risks of rejecting good product or shipping defective product. This two-part webinar series covers: set up, sample sizes, metrics for success, and diagnosing and fixing problems. Practical application of valid statistical software will be illustrated. The material is aimed at quality managers, design & process engineers, and practitioners.

     

    Part 1: Variable Measurement Systems

    Variable measurements are quantitative, such as seal strength, melt temperature, inner diameter, and product concentration. A “User’s Manual” is provided. Highly graphical methods are illustrated for diagnosing problems and improving the measurement system. The presenter’s “keep-it-simple” approach will avoid statistical complexity. Participants do not need to have a background in statistics.

     

    Part 1 Objectives:

    This webinar will provide a working knowledge of the principles and application of Variable TMV. As such, participants will:

    • Be able to quickly analyze results, diagnose problems, and improve a measurement system
    • Learn the quality metrics and industry standards used to evaluate the effectiveness of a measurement system
    • Know how to interpret the output from popular statistical software tools
    • Learn some techniques to deal with destructive testing
    • Understand how to apply this valuable methodology in Design Control and Process Validation

    Part 2: Attribute Measurement Systems

    This second webinar will focus on Attribute Measurement Systems. That is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? This webinar will provide simple metrics to evaluate the human performance and industry best practices to reduce variation.

    Attribute measurements typically end up with a “Pass/Fail” or “Accept/Reject” decision. This webinar provides a practical approach to conducting Attribute TMVs. Participants will gain a working knowledge of how to organize an Attribute TMV, collect data, analyze the results, and improve the measurement system.

     

    The presenter’s “keep-it-simple” approach will avoid statistical complexity. Participants do NOT need to have a background in statistics.

     

    Part 2 Objectives:

     

    This webinar will provide a working knowledge of the principles and application of Attribute TMV. As such, participants will:

     

    • Learn the quality metrics and industry standards used to evaluate the effectiveness of an attribute measurement system
    • Understand how to quickly analyze results, diagnose problems, and improve a measurement system
    • Understand how to apply this valuable methodology in Design Control and Process Validation

     

    Registration

     

    Test Method Validation - Part 1 and 2
    $499

    Register

     

    Meet your instructor:

    Peter L. Knepell

    Peter Knepell

    Peter L. Knepell, PhD, CQE 
    President, Peak Quality Services 

    Dr. Knepell is president of Peak Quality Services in Colorado Springs, CO. Since 1988, he has trained thousands of professionals in quality systems and quality improvement methodologies. His past clients include: Heritage Valley Health System, Novo Nordisk, GlaxoSmithKline, Amgen, Siemens Healthineers, GE Healthcare, Roche Diagnostics, Medtronic, Stryker, Zimmer, Draeger, Varian, Baxter, and Johnson & Johnson. 

    Knepell helps his clients apply innovative methods and technologies to enhance process quality improvement. These include: process validation, risk management, statistical process improvement, and Lean Six Sigma. For example, he directed a team that developed a Continuous Process Validation system for a large pharmaceutical firm. This system integrated a database with a graphical user interface (GUI) and a sophisticated statistical package. It was a validated system that met FDA regulatory requirements. It was used to display and analyze historical and real-time data to monitor and improve product quality. 

    A graduate of the U.S. Air Force Academy, Knepell received his doctorate degree in operations research from Cornell University. As a tenured professor at the Air Force Academy, he used statistical tools and knowledge-based management techniques to inspire innovative thinking and group problem solving. He is a Certified Master Black Belt. He is recognized as a Certified Quality Engineer (CQE) and Software Quality Engineer (CSQE) by the American Society for Quality. He co-authored the book, Simulation Validation: A Confidence Assessment Methodology and contributed to the text, Understanding Industrial Designed Experiments. 


    Virtual Training Information

    Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

    For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.