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Training on How to Conduct a Remote Medical Device QMS Audit

Remote auditing is not new but successful remote audits require teams to be trained on how to do so effectively. Now that just about everyone is comfortable using remote video conferencing and securing file-sharing tools, acceptance of remote audits has grown. In this virtual instructor-led training class, we’ll teach you how to effectively complete all phases of the audit process remotely. We’ll also explore common challenges of a virtual audit and ways to overcome them. 

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Brief Overview of Our Remote QMS Auditing Course for Medical Device Manufacturers

SkillsLab Class ?

Class Content

In-Depth

Class Duration

2 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Option

Virtual Only*

Certification of Completion

Yes

Continuing Education Units (CEU)

0.8

* There is no in-person option for this class. 

Upcoming Classes

Upcoming Remote Auditing Training Courses

SkillsLab $1195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Class on Virtual Medical Device Auditing

This course teaches participants how to conduct a remote audit that meets the audit’s objectives. Targeted at experienced auditors, class participants review how to effectively complete all phases of the audit process in a remote format, and explore common challenges of remote audits and ways to overcome them. 

Course Overview
SkillsLab Class

Establishing the Validity and Effectiveness of the Remote Audit

  • Definitions related to remote auditing
  • Standards and guidance related to remote auditing
  • The characteristics of an effective audit
Exercise! Create a Briefing on Remote Audit Validity and Effectiveness to Share with a Decision Maker

Identifying Remote Audit Issues

  • Review the audit activities in ISO 19011:2018 clause 6
  • The role of technology
  • The relevance of risk analysis when using remote audits
Exercise! Identify Potential Issues Raised by Using a Remote Audit

Planning the Remote Audit

  • Challenges related to planning remote audits, including reviewing documented information and assigning audit tasks
  • Best practices for planning remote audits
Case Study! Planning a Remote Audit

Performing the Remote Audit

  • Identify challenges related to performing a remote audit, including hosting the opening meeting, collecting information, verifying information, generating audit findings, and determining audit conclusions
  • Best practices for performing a remote audit
Case Study! Performing the Virtual Audit

Closing the Remote Audit and Following Up

  • Challenges and best practices related to closing a remote audit
  • Challenges related to remote audit follow-up
  • Lessons learned and tips for performing remote audits
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Explain why a remote/virtual audit can be both valid and effective

Explain the relevance of risk analysis when using remote audits

Plan a remote audit

Identify potential issues when performing remote audits

   Identify best practices for performing remote audits
 
Who Should Attend

Who Should Attend

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

  • Internal Auditors
  • Lead Auditors
  • Supplier Auditors
  • Audit Team Members
  • QMS Managers 

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