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New! 

Conducting a Remote Medical Device QMS Audit

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 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.

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.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 11/23/2020 2 $1095.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 01/05/2021 2 $1095.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 02/01/2021 2 $1095.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 03/01/2021 2 $1095.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 03/29/2021 2 $1095.00 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

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

Virtual Days: 2
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 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:

 
VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET (4 hours each day).

Auditor classes that that require a final exam start at 11:30 a.m. ET on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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