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Combination Product Device Supplier Management Training

Understand supplier quality management throughout the life cycle of your combination product.

This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.

 

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Course Detail

What You Will Learn

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

  • Identify regulatory requirements and international standards for supplier quality management applicable to combination products, including ISO 13485:2016, US FDA, ICH, and the EU Medical Device Regulation
  • Describe the life cycle of supplier quality management
  • Describe the role of supplier management in the design development process of a combination product
  • Describe the role of quality agreements in managing outsourced processes
  • Explain the importance of supplier audits and their role in supplier management
  • Establish a risk-based process for evaluating, selecting, and reevaluating suppliers
  • Translate product development and manufacturing needs into purchased product and supplier requirements
  • Develop and maintain an approved supplier list
  • Develop an effective supplier quality monitoring and measurement process
  • Communicate supplier quality management system status to the management team
  • Plan and implement an effective process for verifying purchased product
  • Manage supplier nonconformances and escalation of issues through the supplier quality management and related quality management system processes

Who Should Attend

Personnel involved in sourcing, securing, and maintaining suppliers for combination products that ensure excellent product quality and organizational reputation, including supplier quality and procurement/supply chain managers; product development engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; auditors; and other crossfunctional team members.

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.4

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Eastern time classes run 1:00-5:00 p.m. daily
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

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.

Related Courses

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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