About the Conference

Statistics are scary.

The Quality System Regulation, ISO 13485:2016 and other regulations and standards require statistical analysis of manufacturing processes and product performance.  Many companies are at a loss as to what they actually need to do, and how much is enough?

Even beyond compliance, good statistical analysis provides business benefits – more targeted studies, greater efficiency, a better understanding of processes.

You do not need to become a statistician to comprehend and oversee the appropriate use of statistical methods in medical device development, testing, manufacturing, and postmarket surveillance.

This course is specifically designed for non-statisticians.  No prior statistical training is required.

Who should attend:

  • RA/QA professionals
  • Process engineers
  • Design / Development engineers
  • Postmarket surveillance / complaint managers

 What you will learn:

  • Basic statistical concepts and language
  • Regulations and standards pertaining to statistical analysis
  • How to correlate risk with sampling plans
  • Cpk, Ppk, and other process capability measures
  • Hypothesis testing for product and process characterization
  • Maintaining the validated state with SPC
  • Choosing the best sample size for V&V studies

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • When

  • Thursday, October 12, 2017 - Friday, October 13, 2017
    12:00 PM - 4:00 PM

  • Where

  • University of Miami
    Coral Gables Campus
    Coral Gables, FL 33146
    USA

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