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ISO 14971 and Risk Management Training for Combination Drug-Device-Biologic Products

Risk management for combination products doesn’t have to employ two separate processes – 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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Brief Overview of This Combination Products Risk Management Training Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEU)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Combination Product Risk Management Training Classes

SkillsLab $3295

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!


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Register 3 people, 4th attends free!


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

Course Overview

Here's What We Cover in This Intensive Course on Risk Management for Combination Devices

Learn all facets of the risk management process and associated requirements found in ISO 13485, the ICH Q series, and the US FDA QSR. We will dive into risk analysis, estimation, evaluation, and control. You'll also walk away with the confidence to perform a robust benefit-risk analysis and write a comprehsive risk management report.

Course Overview
SkillsLab Class

Introduction to Combination Products

  • Combination product types
  • Regulatory pathways
  • Manufacturing scenarios

Risk Management Concepts, Standards, and Requirements

  • Review the basic terms and evolution of risk management in the global regulatory community
  • Risk management standards
  • Risk considerations in ISO 13485:2016, the ICH Q series, and the US FDA QSR
  • Purpose of the risk policy
  • Risk management as a QMS process
Case Study! Describe Combination Product

Risk Management Process

  • ISO 14971:2019 and ISO/TR 24971:2020
  • The risk management process described in ISO 14971:2019 and ICH Q9
  • Define key terms, including reasonably foreseeable issue, hazards, hazardous situations, and harm
  • Risk acceptability criteria
Case Study! Questions to Ask
Case Study! Risk Management Plan

Risk Assessment and Risk Analysis

  • Risk assessment and risk analysis
  • Intended use and reasonably foreseeable misuse
  • Characteristics related to safety
  • Hazards, hazardous situations, and harm
Case Study! Risk Analysis

Risk Estimation and Evaluation

  • Choosing risk tools
  • Design and process failure mode and effects analysis (dFMEA and pFMEA)
  • Preliminary hazard analysis (PHA)
  • Fault tree analysis (FTA)
  • Hazard analysis and critical control point (HACCP)
  • Hazard and operability analysis (HAZOP)
Case Study! Risk Analysis – Apply Tools
Case Study! Risk Analysis – Apply Tools, Cont.

Risk Control

  • Approaches to risk control: ISO 14971, US, EU
  • Risk control process
  • Option analysis
  • Implementation of risk controls
  • Residual risk evaluation
Case Study! Risk Controls

Benefit-Risk Analysis Basics

  • Benefit-risk analysis and ISO 14971:2019
  • Approaches to benefit-risk: US and EU

Production and Postproduction Risk Management Activities

  • Risk management review
  • Risk management report
  • Production and postproduction activities
  • Information collection and review
Case Study! Risk Management Report
Case Study! Postproduction Information
What You Will Learn

What You Will Learn

At the conclusion of this training class, 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

Identify production and postproduction risk management requirements, including corrective and preventive action (CAPA) activities and postmarket surveillance processes

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

Who Should Attend

Anyone from the pharmaceutical and medical device industry 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 13485:2016.

  • RA/QA Professionals
  • Design Managers and Engineers
  • Internal Auditors
  • Manufacturing Personnel
  • Combo Product Team Members

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