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Combination Products: From Regulatory Strategy to Postmarket Surveillance

Understand the unique regulatory requirements of combination products and apply best practices throughout the life cycle of a combination product.

This course provides an overview of combination products and explores the regulatory challenges of a product that combines a medical device with a drug and/or biologic. In this course, through exercises and case studies, you will learn how to identify and apply Good Manufacturing Practices (GMPs) to combination products. You will apply best practices in managing the product life cycle of combination products, from premarket through postmarket activities.

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Course Detail

What You Will Learn

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

  • Determine types of medical device and drug/biologic combinations and the impact of performance claims
  • Establish primary mode of action in determining classification of combination product and subsequent regulatory strategy
  • Identify the applicable regulations, standards, strategies, and agencies involved in developing and marketing combination products
  • Define quality system requirements for combination products, creating a gap-free system to address these requirements
  • Identify similarities and differences between device and drug requirements during product realization and postmarket activities, using a life-cycle approach

Who Should Attend

Quality, regulatory, and technical professionals in primarily device or pharma industries seeking to understand the integration of these sectors, as well as those currently working in combination product areas seeking to optimize best practices.

  • 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.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • 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

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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