Statistical Techniques for Medical Device Manufacturers: 2-Day In-Person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Statistical Techniques for Medical Device Manufacturers: 2-Day In-Person Seminar  

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Quality Managers, Quality Engineers, Quality Assurance and Quality Control, Regulatory Affairs Managers, Regulatory Affairs Professionals, R&D Managers, R&D Engineers, Product Design and DevelopmentOperations Managers, Production Managers and Supervisors, Manufacturing EngineersRisk Managers, Complaint system team members, CAPA team members

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Seminar Summary:

The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to  (see full course description)

 

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Training Course Syllabus:


Learning Objective:



  • Learn the sections of FDA QSR that require statistical techniques.

  • Understand how to apply the FDA tools to develop a clear understanding of the requirements.


    • Regulation

    • Preamble

    • Small Entity Compliance Guide

    • QSIT

    • Warning Letters


  • Understand the set of statistical techniques in ISO/TR 10017

  • Learn how to implement and apply the ISO/TR 10017 statistical techniques.


Seminar Summary:

The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to  (see full course description)

print this agenda print agenda for the Statistical Techniques for Medical Device Manufacturers:  2-Day In-Person Seminar training seminar

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