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Managing Risks in Combination Products and Drug Delivery Systems

Risk management for combination products doesn’t have to employ two separate processes. See how the device and the drug risk can be managed using the same process.

Learn how to apply ISO 14971:2019 and ICH Q9 risk management from both a combination product focus and a process focus. The course also discusses how to select and apply risk management tools through all phases of a combination product’s life cycle.

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Course Details

What You Will Learn

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

  • Identify integration of risk into the US FDA quality system regulation (QSR)
  • Identify similarities between the ICH series and ISO 13485 in quality risk management
  • Describe the key concepts of ISO 14971 and ISO/TR 24971 – including the definitions for benefit, state of the art, and reasonably foreseeable misuse – and the expanded requirements for production and postproduction activities
  • Describe the risk management process, including planning, analysis, evaluation, control, benefit-risk, and residual risk analysis; risk management review and reporting; and production and postproduction activities
  • Describe how to use the process and risk-based approach of ISO 13485 and ICH Q9 to ensure the continued suitability, adequacy, and effectiveness of your risk management process
  • Apply risk management to product safety using ISO 14971 by creating a risk management plan, applying tools for risk assessment and risk control, conducting a benefit-risk analysis, and creating a risk management report

Who Should Attend

Anyone from the pharmaceutical and medical device industries involved in development of combination products, including regulatory personnel. Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, internal auditors, and regulatory affairs professionals; and other cross-functional team members in combination product manufacturing. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


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

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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