How to Implement Risk Management Principles and Activities within a Quality Management System

Who Should Attend

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

This program 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 identification assessment and control of business risk.

Learning Objectives

Upon completion of this course, attendees will understand how to effectively meet the requirements of risk management for medical devices, pharmaceutical and biologics products and processes.  Emphasis will be placed on the effective use of resources in a production and quality system environment by developing strategies based on risk.

The first day will cover the general context for risk management, required procedures and the discussion of the requirements for medical devices and for pharmaceutical/biological products.  Specifically, for medical devices, the requirements of ISO 14971, FDA, GHTF will be reviewed.  For pharmaceutical products, we will discuss the requirements of ASTM 2500-07 and ICH Q9 and its relationship to ICH Q8 and Q10.  The similarities and differences between these two will be covered.  The second day will discuss and apply key risk management techniques (ie FTA, FMEA and HACCP) which will be covered as they relate to product and production processes.  The application of risk management to quality systems will also be examined.

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 mitigate risks.  Additionally, the curriculum provides attendees with the skills to use, maintain, and extend the functionality of a risk management system by effectively analyzing and producing firm-wide risk management tools and measures.

Specifically, this training will teach and reinforce the skills needed to acquire data from disparate data sources, configure your risk environment, develop appropriate risk factor models, perform risk analysis and create results-based reports.

Topics cover current US and international regulatory requirements with respect to development and implementation of effective risk management.  A focus will be placed on basic regulation and the Global Harmonization Task Force’s recent supplemental guideline on “Implementation of Risk Management Principles and Activities within a Quality Management System”

Among the topics to be discussed are: FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis, and HACCP (Hazard Analysis and Critical control Points).  These will be applied to both products and processes and extended to include the application of risk management to a Quality Management System.   The QMS elements include Corrective and Preventive Action, Supplier Management, Change Control, Complaints, Internal Audits, and Design and Development including Verification and Validation.

This course will also provide participants with a systematic approach for recognizing potential failure modes and analyzing effects for product design and manufacturing processes.  Once potential failure modes have been identified a process FMEA can be used to identify the level of validation testing.