Industries: Pharma / BiotechMedical Device

Integration of Risk Management Principles and Activities into the Quality System

Course Director: Jonathan Lee

Course Description - Course runs 9:00 to 5:00 both days

The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry.  Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed

New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with Quality Management Systems re-build confidence for the three major stakeholder groups: Regulators, Industry and most importantly the Medical Community - including users & patients.

This course will cover Risk Management principals associated standards and practices together with how to develop, apply and implement strategies that reduce risks in the areas of drugs, devices and IVDs while working within established Quality Management Systems.

Topics covered include:

  • Current US and international regulatory requirements
  • Review & application of International Council for Harmonization Q8, Q9, Q10
  • Consideration of ISO 14971 and IMDRF (previously Global Harmonization Task Force) Medical Device Risk Management principals within a QMS
  • Risk Based approach for assessment of In Vitro Diagnostic

The course will identify the close link between Risk Management and QMS elements such as: Design Controls, Corrective and Preventive Action, Supplier Management, Change Control, Complaint Handling, and Production and Process Control

Who Should Attend

This two-day course is designed for quality managers, engineers, auditors, regulatory/quality compliance professionals, clinical & product specialists, R&D engineers, laboratory professionals, product development professionals, production managers and top management interested in learning the value of risk management principals and integration with Quality Management Systems to better utilize resources and data to optimize the risk management processes.

The overall goal of this training is to establish awareness and practical understanding of the advantages of integrating QMS & Risk Management to enhance sustainability of both product and business by improving patient safety, clinical outcomes and business predictability.

This training will provide a broad introduction to the subject of risk management for both new and more experienced personnel, including middle and upper management.  Participants will broaden and update their knowledge of US and international risk management requirement

Course Agenda

First Day

Introduction to Risk Management

  • Definitions
  • Why Risk Management

Regulatory Perspective

  • Major Standards to Consider
  • Understanding the different perspectives of risk management as they relate to medical devices, pharmaceutical and
  • iopharmaceutical products
  • Reviewing the role of ICH on approaches toward risk management
  • Reviewing recent warning letters from a risk management perspective

Risk Management Process

  • Understanding the terms used in risk management
  • Discussing what risk is
  • Understanding the elements of an effective risk management process
  • Training the organization on the principles of risk management

Comparison of Risk Management Requirements

  • Review the requirements of ICH Q9 and related Q8 and Q10 for pharmaceutical and biopharmaceutical products
  • Review the requirements of FDA, ISO 14971:2007 and GHTF guidance document on risk management for medical devices
  • Consider the unique challenges of the application of risk management to medical device and pharmaceutical organizations
  • Introduction of the tools of risk management (i.e. FMEA, Risk Matrices and Fishbone)

Group Discussion:

  • Bring your own current risk related problem and we will work together to find possible solutions/strategies

Implementing Risk Management in Your Organization

The importance of the right culture and people

  • Role of leadership in risk management
  • Establishing the organizational culture necessary for an effective risk management process
  • Developing a risk management policy and establishing goals and objectives
  • Defining process ownership and participants
  • Different or unique requirements for both the medical device and pharmaceutical industries

The Process Frame

  • Establishing the ground rules, procedures, forms and mechanism for risk analysis
  • Training for risk management competence
  • Obtaining participant commitment
  • Determining responsibilities and roles for the execution of risk management

Starting the Risk Management Process

  • Conducting the initial risk management gap analysis
  • Identifying the starting point for applying risk management
  • Executing a risk analysis (RA)
  • Reporting and monitoring Risk Management Program performance and progress
  • Determining when mitigations are sufficient
  • Identifying inputs to the living risk management system

Second Day

Expanding the Application of Risk Management: The Application of Risk Management to the Quality Management System

The Application of Risk Management to the Quality Management System

  • ASTM 2500
  • EN 60601
  • EN 62304
  • ICH Q9
  • ICH Q8
  • ICH Q10
  • WHO Guidance on HACCP
  • GHTF guidance document

Recognizing and Understanding the Tools of Risk Management

Working Session I:

  • Participants will be divided into groups and given a case study and be asked to perform a Risk analysis on an organization. Each group will present the results of its analysis

Working Session II:

  • Participants will be divided into groups and given a case study and be asked to perform a risk analysis of a product or process using appropriate RM tools for the specific problem. The results of the analyses will be shared in the class.

Challenges with Implementing Risk Management

  • Overcoming the pitfalls

General Discussion and Questions

Learning Objectives

Upon completion of this course, attendees will understand how to effectively meet and integrate the requirements of Quality Management and Risk Management in the health product areas of Medical Devices, Pharmaceutical/Biopharmaceuticals and IVDs.

Course Objectives Include:

  • Develop an understanding of the general context for risk management and the terms and their relationships
  • Understanding the different risk requirements between Devices, Pharma & IVD
  • Appreciate the significant Risk Management requirements, standards & guidance’s
  • Understand the role & contribution of key harmonization groups
  • Understand the regulatory agency expectations
  • Appreciate the significance of product life cycle considerations
  • Identify and understand the specific key guidelines, regulations & standards
  • Develop an appreciation of tools used in Risk Assessment and Management;s
  • Understanding how the Risk Management process is started and maintained
  • Understand the scope, breadth and utility of publications sourced from regulatory, harmonization & standards groups
  • Develop an understanding and skill for integrating Risk Management practices into a Quality Management System
  • Identifying and overcoming challenges with implementation
  • Establishing a consideration for a wider application of Risk Management principals to business



"The course was a very good introduction to the concept of integrating Risk Management into the existing Quality management System. It was well presented and well explained." Ladi O., Device Safety Leader, Bayer
"Great course, great spokesperson! Highly recommend! I for one especially appreciated the following, Real-life examples from all walks of business, Providing the standard, laws and guidance from a global perspective was very refreshing and enlightening and the Workshop was great as well." Goldi, Director, Pharm. Tech., Otsuka
"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