2013 Barcelona Training, September 2014


Applying Quality Risk Management (QRM) (T42)

Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Primer Webinar





26 - 27 Sep 2016 Barcelona Spain Ms. Alice Redmond, PhD
19 - 20 Oct 2016 Boston, MA USA Mr. Michael R. Porter


Quality Risk Management (QRM) principles require the evaluation of risk to quality based on scientific knowledge and the protection of the patient. Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9. The application and the complexity of risk management tools need to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny, and the overall approach should be defined in a formal Risk Management Plan (RMP). To date the application of ICHQ9 is evident in risk based approaches to commissioning and qualification, but to a lesser extent holistically throughout the product lifecycle.

Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle, including but not limited to:

  • All processes, tests, systems, equipment and facilities related to the clinical and commercial manufacturing of products
  • New product and process development and transfer
  • Change control
  • Vendor selection and qualification
  • Supplier management
  • Corrective and preventive actions
  • Complaint handling
  • Deviations
  • Inspections, both internal and external
  • Training
  • New regulatory requirements
  • Trends from quality indicators, periodic quality and product reviews
  • New business strategies that may have a critical impact on the quality system
  • Stability monitoring
  • Validation approach

This course will dive into specific strategies and discussions on important elements of QRM such as defining the criteria for risk ratings and risk mitigation requirements; the importance and necessity of tracking and monitoring the outputs of risk assessments; and how to use risk assessment outputs for trending and process improvement.

Applied Risk Management Cover

Immediately apply the course objectives using the complimentary copy of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification and the ICH Q8(R2), ICH Q9 and ICH Q10 booklets.

NOTE: It is strongly recommended that participants be familiar with basic concepts of ICH Q8(R2), ICH Q9 and ICH Q10 and have a fundamental understanding of risk-based C&Q prior to attending this course.


We recommend participants complete the primer course webinar that provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10, and the basic concepts of risk-based commissioning and qualification to provide a foundation to the QRM process.

This course includes the primer webinar. Access information will be provided via email one week prior to the start of the training event.

Course Modules

Day 1

  • History and Introduction to Quality Risk Management
  • Regulatory Overview
  • Risk Management Plan Development and Implementation
    • Risk Management Roles and Responsibilities
    • Breakout – Development of a Risk Management Plan Outline
  • The QRM Process
    • Risk Identification
    • Risk Assessment
    • Risk Evaluation
    • Risk Control (Reduction and Acceptance)
    • Ranking and Trending
    • Reports and Outputs
    • Breakout – What Your Company Needs to Establish a Formal QRM Program
  • QRM Tool
    • Breakout – What tool is suitable and when?

Day 2

  • Review of Day 1
  • QRM Tools, continued
    • Breakout – Practice Risk Assessment
  • Risk decision tree/matrix
    • Breakout – Application of a risk decision tree
  • QRM Across the Product Lifecycle
    • Implementation of QRM from Design to Decommissioning
  • Conclusions/Summary

Take Back to Your Job

  • Summarize US, EU and WHO regulatory requirements, citations and expectations that may influence the implementation of a holistic QRM process
  • Understand the philosophy and application of a holistic lifecycle-based QRM process through the development of a Quality Risk Management Plan
  • Learn how to develop and implement a risk decision tree and the appropriate use of risk assessment tools
  • Understand the expected format of the risk management plan and file inclusive of risk ranking
  • Develop the ability to apply risk management methodologies throughout the product lifecycle
  • Understand best practices and lessons learned from implementing QRM and how to conduct effective risk assessments
  • Understand the Risk Based Approach for the Delivery of Facilities, Systems, Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
  • Understand how these documents align with the overall implementation of a robust QRM system that is applicable for the product lifecycle

Attendance Suggested For

  • Intermediate and management level Quality and Compliance Managers.
  • Intermediate practitioners of Commissioning and Qualification who want to understand and use QRM
  • Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory

Community of Practice (COP)

This training course is of particular interest to existing and future members of the Commissioning and Qualification ISPE Communities of Practice.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
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  • EU Training Sponsor

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