Course Overview

Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.

This interactive, advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.

Covered Topics

Section 1 will dive into specific strategies and discussions on the essential elements of a QRM program as defined in ICH Q9 and will utilize numerous breakout sessions to allow participants to consider improvements for their company’s QRM program and network with other participants to share best practices. Specific topics covered include:

QRM Program Overview

Regulatory Overview

QRM Elements

Roles and Responsibilities

Risk Planning

Risk Assessment

QRM Tools

Risk Control

Risk Reports and Outputs

Section 1 Summary

Section 2 provides insight into strategies for effective risk assessment facilitation including warning signs in team dynamics that facilitators should monitor and eliminate. These discussions will include breakout sessions for deeper discussion and prepared case studies for facilitation preparation and practice. Specific topics covered include:

a)     Facilitation Skills

b)     Human Heuristics

c)     Cultural Influences on QRM

d)     Factual case studies led by the instructors

     Section 3 provides time for participants to share their specific risk assessment challenges and facilitate successful risk assessment outcomes. Participants should come prepared to work in groups to discuss their own real-life challenges and devise workable and creative solutions to realistic problems and case study scenarios, facilitated by expert trainers. By working through selected participant case studies, participants will gain experience in facilitating and executing formal risk evaluation tools like FMEA and informal risk tools to facilitate brainstorming like Fishbone, 5-whys and FTA.

Course Summary

While some case studies will be provided, participants are invited to bring examples (made generic or non-specific if necessary) where they have found application of risk tools challenging for the group discussion and engagement. Case studies may come from any area of the business where QRM is applied such as:

a)     New product and process development and technology transfer

b)     Quality Management System elements:

c)     Change controls

d)     Deviations

e)     Complaint investigations

f)      Prospective or Retrospective Validation

g)     Vendor selection

Who Should Take the Course?

This course is designed for any individual responsible for quality or technical support activities relating to testing, sampling or calibration activities within their organization. This could include:

Risk Management

Product development

Quality assurance, quality control, compliance, project engineers and managers

Commissioning, validation

Engineering service providers

Manufacturing operations and facilities professionals

Education and/or Experience and/or Prerequisites

You must at least have one (1) year of on-the- job experience in any Engineering discipline.

Work experience must be in a full-time, paid role. Paid intern, co-op, or any other course work cannot be applied toward the work experience requirement.

Study Material

The Training is based on both theory and best practices used in AMS Audit

Lecture session illustrated with example based on case studies

Practical exercises as based on case study as includes role playing and discussion.

End of Course

After Completing the session and passing each session examination, the student can take final exam. Once the final exam is cleared, then it is considered as end of course.

Course Duration

• 2-3 days