Integration of Risk Management Principles and Activities into the Quality System

Available Locations


Course Description

Risk management is a practice with processes, methods, and tools for managing risks in a project.  It provides a disciplined environment for proactive decision making to continuously assess what could go wrong within an organization and with its products.  This course will cover which risks are important to deal with and how the implementation of strategies can reduce and mitigate risks. 

Topics cover current US and international regulatory requirements with respect to development and implementation of effective risk management program.  A focus will be placed on ICH Q9 and an overview of ISO 14971.

The QMS elements to be covered are Corrective and Preventive Action, Supplier Management, Change Control, Complaints, Management Reviews and Audits.

This course will also provide participants with a systematic approach for identifying potential failure modes and analyzing effects for product design and manufacturing processes.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend

This two-day course is designed for quality managers, engineers, auditors, regulatory/quality compliance professionals, laboratory professionals, product development professionals, production managers and top management interested in learning the value of risk management principals and how to improve existing systems by better utilizing resources and optimization of risk management processes.

The overall goal of this training is to raise awareness for Quality Risk Management to enhance sustainability of your business by improving patient safety and outcome.

This training will provide a broad introduction to the subject of risk management for more experienced personnel, including middle and upper management.  It will allow participants to update and broaden their knowledge of US and international risk management requirements.  It explores both the positive and negative aspects of risk and aims to improve knowledge and practical skills in the assessment and control of quality risks, clinical/patient risks and ultimately business risks.

Learning Objectives

Upon completion of this course, attendees will understand how to effectively meet the requirements of quality risk management for medical devices, pharmaceutical and biopharmaceutical products and processes. 

The first day will cover the general context for risk management, required procedures and the discussion of the requirements for pharmaceutical/biopharmaceutical products and medical devices.  For pharmaceutical/biopharmaceutical products, we will discuss the requirements of ICH Q9 and its relationship to ICH Q8 and Q10.  For medical devices, the requirements of ISO 14971 will be reviewed.

The second day will be a discussion on variety of risk management tools and how to select the right tool for the right problem?  In addition to Quality Risk Management the application of risk management to laboratory systems and drug development will also be examined.

Review of ICH Q7, Q11 and Q12 by request.

Past Participants' Comments:

"The material was thorough and comprehensive. The Course Director is clearly an expert on risk management and the right person to teach the course. He is articulate, patient, and can cater the material to an audience in many different groups and industries. In addition, he has created several useful workshops that forced the class to apply the risk management principles he was teaching." Jonathan K., Quality Systems Specialist, Boehringer Ingelheim Chemicals
"All course materials were helpful, especially the worksheets. I will be able to bring them back to my company and start using them to improve our processes. Instructor gave good insight into the FDA perspective and what an investigator would be looking for in a risk management plan." Leah S. Proc. Development Engineer, Alkermes
"Excellent course, well delivered and useful notes I can refer to later. Good group exercises." Michael K., Department Manager, PM Group
"This class will enable me to network and gain a better understanding of risks. Great job!" Kim B., Manager of GMP Quality, Merck
"The Course Director was excellent in explaining material. When I came in, I didn’t know much about the topic and when I left on the last day I felt like I could share ideas with others." Melissa R., Scientist, Business Operations, Glaxo (GSK)
"The exercises give 'practical application' to the information given in the lecture." Christy, S., Quality Assurance, W.L. Gore & Associates
"This course provided excellent tools that we will be able to implement immediately." Scott W., QA Manager Johnson & Johnson
"The complicated topics were made simple and understandable for new QA staff." Raymond N., Sr. Medical Advisor & Safety Officer, Baxter