Valid Statistical Techniques Made Easy Part 2
Valid Statistical Techniques Made Easy Part 2
English | Intermediate Level | Presentation | 1 hour and 56 minutes
Corresponds to 1 day of teacher-directed learning
Description
In the previous webinar we asked: How do you know you have quality if you cannot reliably measure what you are doing? 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? And how is it made easy? This webinar will provide simple metrics to evaluate the human performance and industry best practices to reduce variation. It's as simple as that!
Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). The name is not important, the application of this very valuable statistical methodology is essential for a quality system. The material covered in this webinar is completely independent of the first webinar on Variable TMV. Thus, attending the first webinar on Variable TMV is NOT a requirement to attend this webinar.
Attribute measurements typically end up with a Pass/Fail or Accept/Reject decision. This webinar provides a very 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.
This webinar is targeted to professionals concerned with the application of valid statistical methods and tools to satisfy the requirements of the FDA:s Quality System Regulation and ISO 13485:2016. In particular, the Attribute TMV methodology is important for Design Control and Process Validation.
This webinar will provide a working knowledge of the principles and application of Attribute TMV/MSA/GR&R. As such, participants will:
Learn the quality metrics and industry standards used to evaluate the effectiveness of a 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
Learn some techniques to deal with destructive testing
This webinar is targeted to professionals concerned with the application of valid statistical tools and methods to meet the requirements of the FDA's Quality System Regulation. As such, the content should have great value to individuals in industry who are involved with: research and development; new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; and regulatory compliance. In addition, managers and members of the leadership team will see how value is added to a product or process by applying this valuable methodology.
There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our keep it simple approach.
Content
- Review of Questions from Part 1 Webinar on Variable TMV
- Destructive Testing - Four Techniques from Industry
- Address Emailed Questions
- Fundamentals of Attribute TMV/MSA/GR&R
- Definitions and Terminology
- Quality System Regulation and Guidance Documents
- Significant Trends and FDA Warning Letters
- How to Run an Attribute TMV
- Organizing an TMV
- Conducting an TMV
- Improving an Attribute Measurement System
- Industry Best Practices
- Technical Details
- Attribute TMV Metrics
- Sample Size
Course module
1. Valid Statistical Techniques Made Easy Part 2
This is dr. Peter Kneppel's lecture Valid Statistical Techniques Made Easy Part 2.
Trainer: Peter Kneppel
Duration: 1 hour and 56 minutes (Total duration of the course: 1 hour and 56 minutes)
Course material
There is no additional course material for this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Peter Kneppel
Dr. Pete 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 several defense agencies, the Canadian Red Cross, Sony, Corning, Texas Instruments, Xerox, Hewlett Packard, Heritage Valley Health System, GlaxoSmithKline, Amgen, GE Healthcare, Roche Diagnostics, Creation Technologies, SORB Technology, Baxter, Medtronic, Stryker, Zimmer, Varian, Ventana Medical Systems and Johnson & Johnson.
He helps his clients apply innovative methods and technologies to enhance process quality improvement. These include process validation, risk management, statistical process improvement, software quality improvement and Lean Six Sigma. For example, Pete 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 meets FDA regulatory requirements. It was used to display and analyze historical and real-time data to monitor and improve product quality.
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