This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
All processes exhibit intrinsic variation. However, sometimes the variation is excessive and this hinders the ability to achieve reliable measurements and desired results. Statistical process control (SPC) and statistical quality control (SQC) allow us to control the functions of our processes (input) and the quality of our product (output) by providing tangible tools for monitoring and testing.
The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring information (data) that is objective, unbiased, and useful for decision making.
Process and quality control are important for a company’s reputation. A good system of processing and quality checks reduce costs associated with production waste and re-work due to defects, and allows a company to deliver products that are high in quality. Many industries are also required to have a good quality management system in place to achieve compliance with regulatory authorities.
The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and monitoring tools within the statistical framework.
Presented examples will include an emphasis on the manufacturing processes and quality assurance needs of product in the medical device and pharmaceutical industries.
Process and quality control are constantly evolving. Therefore, historical concepts, current trends and regulatory requirements will be discussed. The presentation of statistical charts and analyses, graphical techniques for planning, trouble-shooting and problem solving will also be presented. Minitab statistical software will be used to demonstrate data collection and input, and how to build and interpret various process control charts for both attributes and variables data. The seminar will also include the use of Minitab to develop attributes and variables sampling plans for quality assurance and acceptance. A handout and dataset will be provided to attendees so they may work hands-on with the information presented in the seminar.
Who will Benefit:
- Quality assurance (QA) engineers
- Quality control (QC) engineers
- R&D engineers
- Process control personnel
- Manufacturing/Industrial personnel
- Manufacturing/Industrial personnel
- Production supervisors
- Management personnel of processing facilities
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
February 23rd, 2023 (10:00 AM - 4:00 PM PST)
- It’s a System! Elements of Quality Management
- Deming 14 points for total quality management
- Dr. Ishikawa, seven quality control tools (7-QC) and supplementals (7-SUPP)
- Pareto principle (80/20 rule)
- Shewhart (Plan, Do, Study, Act)
- Regulatory Requirements in Quality Management
- FDA Quality System Regulation (QSR)
- ISO 13485:2016
- IS 9001:2015
- Harmonization of regulations with FDA guidance/regulations
- Statistical basics
- Descriptive and Graphical Techniques
- Normal Distribution
- Histograms
- Scatterplots
- Pareto charts
- Cause and effect (fishbone) diagrams
- Defect concentration diagrams
- Descriptive and Graphical Techniques
- Statistical Process Control: The ABC’s of Control Charts
- Elements of a control chart
- Control Charts for Discrete Data
- c chart
- u chart
- p chart
- np chart
- Control Charts for Continuous Data
- X-bar chart
- R chart
- I chart
- MR chart
- Combined charts (Xbar-R, I-MR)
- More Control Charts
- Classical Shewhart control charts
- Cumulative Sum (CUSUM) charts
- Exponentially Weighted Moving Average (EWMA) charts
- Hotelling (multivariate) control charts
Elaine Eisenbeisz
Owner, Omega Statistics
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers. In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics. Elaine received her Master’s Certification in Applied Statistics from Texas A&M and continues to learn from her practice. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She designs and analyzes studies as a contract statistician for pharmaceutical and proton therapy research. She also works on nutriceutical and fitness studies. Elaine works as a contract statistician with numerous private researchers, CRO’s and biotech start-ups as well as with larger companies such as Allergan, Intuitive Surgical, Guardant Health, Nutri-System, Amazon, and Rio Tinto Minerals.
Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
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