FDAnews Announces Statistical Techniques for Medical Device Manufacturers Virtual Workshop Dec. 15, 2020 • 10:00 a.m.-4:30 p.m. EST

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Upgrade the efficiency and effectiveness of quality management system’s with simple statistical techniques one can learn in a day.

WCG FDAnews

WCG FDAnews

Statistical Techniques for Medical Device Manufacturers
A Virtual Workshop Presented by FDAnews and Ombu Enterprises
Tuesday, Dec. 15, 2020, 10:00 a.m.-4:30 p.m. EST
https://www.fdanews.com/stattechmdworkshop

Want to upgrade the efficiency of quality management system’s (QMS) and make it more effective? The answer is statistics — and one doesn’t need to be a statistician to benefit.

While regulations don’t require the use of statistical techniques, devicemakers with the most robust QMS employ them regularly. Without statistics bolstering QMS, the likelihood of getting FDA approval or a CE Mark for devices is significantly reduced.

Come away from this virtual workshop understanding the core statistical techniques most commonly required for QMS, why they apply, choosing the technique and common applications, how they work (without too much math!) and how to implement them in Microsoft Excel — no fancy statistical software packages required. In fact, the focus will not be on calculation, but on correct application, data integrity and understanding the results.

Dan O’Leary, President of Ombu Enterprises, chose the techniques based on ISO/TR 10017:2003, which describes statistical techniques for a QMS, and touches on other methods available, so attendees will get the guidance needed to make QMS work to its best advantage. He’ll include the regulatory requirements from both QSR and ISO 13485:2016, and he’ll share real-life warning letters to illustrate problems encountered by devicemakers.

Just have a basic understanding of Excel formulas and medical device regulations. It would be helpful to bring a set of descriptive statistics, too. Dan will provide the rest, sharing:

  • Introduction and Basic Statistics
  • Summarizing Data with Statistics

        - Probability Distributions
        - Graphical Methods

  • Understanding Data Over Time

        - Run Charts
        - Time Series Analysis
        - Statistical Process Control Charts

  • Data Modeling

        - Regression Analysis
        - Predictive Analysis
        - Shelf Life Estimation

  • Measurement Analysis

     - Measurement Uncertainty
     - Measurement System Assessment

  • Acceptance Sampling

     - Attribute Methods
     - Variables Methods

  • Hypothesis Testing

Move QMS ahead with these statistical techniques.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Virtual Conference Details:
Statistical Techniques for Medical Device Manufacturers
A Virtual Workshop Presented by FDAnews and Ombu Enterprises
Tuesday, Dec. 15, 2020, 10:00 a.m.-4:30 p.m. EST
https://www.fdanews.com/stattechmdworkshop

Tuition:
Pricing: $597

Easy Ways to Register:
Online: https://www.fdanews.com/stattechmdworkshop
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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