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Medical Device Supplier Quality Management Training

Can't travel? This class is available as a online, virtual seminar!

Updated to reflect new EU and MDSAP requirements for effective supplier management.

Poorly designed and executed supplier quality management systems can cost your company millions. With dozens or hundreds of suppliers to manage, you need a proven risk-based process that meets FDA and ISO 13485:2016 requirements, plus new mandates found in the EU Medical Device Regulation (MDR 2017/745). On paper, the requirements seem straightforward, but applying them can get tricky.

You’ll walk away from this 3-day training with a clear understanding of the various regulatory requirements and how to establish an effective and efficient system using a risk-based approach.

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Course Detail

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Identify requirements for supplier quality management, including ISO 13485:2016, US FDA, MDSAP, and the EU MDR.
  • Establish a risk-based process for evaluating, selecting, and reevaluating your suppliers.
  • Translate needs into purchased product and supplier requirements.
  • Develop and maintain an Approved Supplier List and manage your outsourced processes.
  • Understand the elements of a good quality agreement and when they are needed.
  • Implement an effective process for verifying purchased product and monitoring ongoing supplier performance.
  • Manage supplier nonconformances, escalation of issues, and supplier change notification.
  • Create clear product specifications and head off potential issues before they occur.
  • Identify and resolve supplier issues before they escalate.

Who Should Attend

Anyone involved in sourcing, securing, and maintaining critical suppliers and services that affect product quality and organizational reputation. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485. 

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.5

Virtual Session Details

Virtual Session Details

The same great training, from the comfort of your home or office

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, work across various regions or locations, or who just prefer the convenience of attending a class without having to leave their own personal environment.

This class can also be delivered as a private virtual learning exclusively for your company. 

Online Training Schedule

Standard delivery for this class is as five 3.5 hours sessions - daily 1:00 PM to 5:00 PM Easter time.

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

Tablets and mobile devices may lack some essential functionalities and are not recommended.  

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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