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QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements

Course participants will obtain knowledge and practical application experience needed for validating software for use in medical device quality management systems. This includes planning, execution, and reporting of process and computer system validation activities as part of the integrated requirements of a quality management system that meets FDA and ISO 13485 requirements.

At the end of this workshop, participants will be able to:

  • Describe the regulatory requirements for software in the Quality Management System and manufacturing processes
  • Describe the essential elements for a comprehensive and flexible computer system validation (CSV) program.
  • Examine how to implement risk-based and critical thinking to apply the best approach to a specific system.
  • Manage software vendors using a risk-based approach
  • Describe requirements for spreadsheet validation
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Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as 4 consecutive half-day sessions.
  • Daily sessions run from 1:00 - 5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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