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Conducting Remote Medical Device QMS Audit Training

This virtual instructor-led seminar runs as 2-half day sessions.  See virtual delivery details here.

Remote auditing is not new. However, the COVID 19 pandemic brought it into the spotlight as organizations looked for solutions to keep their audit programs on track while “shelter in place” requirements were in effect. Although virtual audits’ benefit of addressing social distancing is becoming less necessary, they are likely not going anywhere. Over the long term, remote auditing will remain a tool that organizations can leverage to save time and expenses while improving efficiency. 

Get Your Remote Audit Started with This Class

Successful remote medical device audits require teams to be trained on how to navigate an audit in a remote context. In this virtual instructor-led training class, we’ll teach you how to effectively complete all phases of the audit process in a remote format using Information and Communication Technology (ICT).  We’ll also explore common challenges of a virtual audit and ways to overcome them.

Oriel STAT A MATRIX is a registered training provider for Exemplar Global. Students who pass the course requirements will earn both a certificate recognized by Exemplar Global as evidence of your competency as well as an Oriel STAT A MATRIX credential in assessing proficiency.

This class is for experienced medical device auditors who want to learn how to conduct effective remote audits. If you need to learn how to audit a Medical Device QMS, consider our  ISO 13485 Internal Auditor or ISO 13485 Lead Auditor class.

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Course Details

Learning Objectives

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

  1. Explain why a remote/virtual audit can be both valid and effective.
  2. Explain the role of risk analysis when using remote audits.
  3. Plan a remote audit.
  4. Identify potential issues when performing remote audits.
  5. Identify best practices for performing remote audits.

Recommended Prerequisite

Oriel STAT A MATRIX courses ISO 13485:2016 Lead Auditor Training or ISO 13485:2016 Internal Auditor Training or equivalent. 

Who Should Attend

This course is intended for medical device professionals who have practical experience in internal or external auditing.

Virtual Class Days

Virtual Class Days: 2 days, daily 1:00  - 5:00 PM ET 

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    0.8

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.

Online Training Schedule

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

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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