Valid Statistical Techniques Made Easy Part 1
Valid Statistical Techniques Made Easy Part 1
English | Intermediate Level | Presentation | 1 hour and 56 minutes
Corresponds to 1 day of teacher-directed learning
Description
How do you know you have quality if you cannot reliably measure what you are doing? Are you afraid of complex statistical concepts and procedures? These two webinars will help you to evaluate your measurement systems, diagnose problems, and fix them. How is it made easy?? This first webinar will provide a User?s Manual to apply valid statistical software to a TMV methodology. The software will yield simple metrics to evaluate the measurement system and graphical tools to identify problem areas and fix them. It´s as simple as that!
Participants receive a working knowledge of Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. Thus, the valid statistical techniques satisfy requirements of: the US FDA´s QS and cGMP Regulations, ISO 13485:2016, and ICH Q2(R1). In particular, the TMV/MSA/GR&R methodology is vitally important for Design Control, Process Validation and Analytical Procedures.
This is the first of two vital webinars on the subject. Part 1 will cover TMV/MSA/GR&R for Variable measurements. Part 2 will cover Attribute (e.g., pass/fail) measurements. We will cover the details of application together with some examples of best practices in industry. Analysis results and graphics from popular statistical software programs will be illustrated. Participants will gain a working knowledge of how to organize a Variable 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 will provide a working knowledge of the principles and application of Variable TMV/MSA/GR&R. 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
Understand how to apply this valuable methodology in Design Control, Process Validation, and Validation of Analytical Procedures.
This webinar is targeted to professionals concerned with the application of valid statistical tools and methods to meet requirements of regulatory agencies and industry standards. 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
- Fundamentals of TMV/MSA/GR&R
- Definitions and Terminology
- Quality System Regulation and Guidance Documents
- Significant Trends and FDA Warning Letters
- Variable TMV Introduction
- Quality Metrics
- Cost of a Poor Measurement System
- Sample Size Considerations
- Set Up and Data Collection
- Reviewing Metrics and Graphics
- Examples from Industry
- Validation of Analytical Procedures (VAP)
- FDA Regulations and Guidance and ICH Guideline (ICH Q2(R1))
- Definitions, Terminology and Mapping to TMV Concepts
- Example from Industry
- User´s Manual for Variable TMV
Course module
1. Valid Statistical Techniques Made Easy Part 1
This is dr. Peter Kneppel's lecture Valid Statistical Techniques Made Easy Part 1.
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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