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Conducting a Remote Medical Device QMS Audit

Remote auditing – or e-audits – are not new. However, the COVID-19 pandemic has put them in the spotlight as organizations are looking for solutions to keep their audit programs on track while “shelter-in-place” requirements are in place. 

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 new virtual instructor-led training class, we’ll teach you how to effectively complete all phases of the audit process in a remote format. We’ll also explore common challenges of a virtual audit and ways to overcome them.

Virtual audits are perfectly acceptable and, beyond the obvious benefits for addressing social distancing, over the long term can be a tool organizations leverage to save time and expenses while improving efficiency.

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.


Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  Private training available, learn more »

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 07/01/2020 2 $995.00 Add to Cart CONTACT US

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

The virtual session is 2 half days.  Each seesion runs 3.5 hours. A typical "PM Schedule" runs from 1:30 PM to 5:30 PM EST.

In-Person Days: 1
CEUs: 0.8

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 3.5 hours sessions.  Each session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.  

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

Technical /Logistical Requirements

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

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The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX Private training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477

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