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Applied Statistics, with Emphasis on Verification, Validation, and Risk Management

Event Details

Applied Statistics, with Emphasis on Verification, Validation, and Risk Management

Time: March 26, 2019 at 9am to March 27, 2019 at 6pm
Location: Homewood Suites by Hilton Houston-Kingwood Parc
Street: 23320 Hwy 59 N. Kingwood, TX 77339
City/Town: Houston, TX
Website or Map: http://www.globalcompliancepa…
Phone: 18004479407
Event Type: seminar
Organized By: John Robinson
Latest Activity: Mar 5, 2019

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Event Description

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft "statistically valid conclusion statements" (e.g., for reports)
  • Summary recommendations

Why should you attend:

Almost all design and/or manufacturing companies evaluate product and processes either to manage risks, to validate processes, to establish product/process specifications, to QC to such specifications, and/or to monitor compliance to such specifications.

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

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