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 regulatory and business requirements for the pharma, diagnostics, and medical-device fields continue to update, blend, overlap, and blur. With these changes, the importance of risk assessment—and risk management—gains higher business and regulatory significance. It now becomes even more important for professionals in these fields to recognize, accept, understand, and respond to these changes —particularly since new regulatory requirements have emerged within this changing environment.

The market’s Tolerance for Failure of Drugs, Devices, and IVDs has reduced significantly in recent decades. This reduction reflects a general loss of confidence in the medical industry. The adoption of formal Quality Management Systems (QMS) has recovered some of that confidence, but we must still do more. This course addresses what we can do.

When integrated with QMS—the collection of policies, procedures, processes, and resources designed to meet customer and regulatory requirements—risk management approaches and requirements can help further build confidence for the major stakeholders; including regulators, industry, and–most importantly–users and patients in the medical community.

Items covered include risk-management and QMS principles—as well as associated standards, and practices. The course addresses how to develop, apply, and implement risk management strategies within a QMS—helping reduce risk associated with drugs, devices, IVDs, and even business practices themselves.

Topics include:

  • Impact of revised International Standards Organization (ISO) standards 13485, 14971
  • Specific review and assessment of ISO 13485:2016 and the three-year transition period
  • Other current and emerging U.S./international regulatory requirements
  • Definitions of standards, regulations, and laws—as well as instances in which these may overlap
  • Review and application to pharma of International Council for Harmonization (ICH) Q8, Q9, Q10
  • International Medical Device Regulators Forum (IMDRF)—previously known as the Global Harmonization Task Force—Medical Device Risk Management principles within QMS
  • Risk-based approaches for assessment of In-Vitro Diagnostics
  • Review of the ISO 31000 definition of “risk” and potential application to business practices

This course examines similarities between the role of ICH in pharma and that of IMDRF in medical devices—including how regulations apply to emerging combination devices. It also identifies links between Risk Management and QMS, including Design Controls, Preventive/Corrective Action, Supplier Management, Change Control, Complaint Handling, and Production/Process Control.

Who Should Attend

This two-day course is designed for quality/production managers, engineers, auditors, regulatory/quality professionals, clinical/product specialists, R&D engineers, laboratory professionals, product-development professionals, and management. Those responsible for Quality System compliance and certification to ISO 13485 are urged to attend. Attendees will learn the value of risk-management principles, integration with QMS, and how to better utilize resources.

This program provides a broad introduction to risk management for both new and experienced personnel, including management. It establishes awareness and understanding of the advantages of integrating QMS and Risk Management. Attendees will learn how to enhance the sustainability of product and business by improving patient safety, clinical outcomes, and business predictability. In workshop exercises applying those principals, participants will broaden and update their knowledge of both U.S. and international risk-management requirements.

Course Agenda

First Day

Introduction to Terms and Definitions

  • What is Risk?
  • What is Risk Management?
  • What are Quality Management Systems?

Regulatory Perspectives and Requirements

  • Understanding the difference between: laws, regulations, standards, guidances, and methods
  • Major standards and guidances for Pharma, Medical Device and IVD
  • Reviewing the contribution of ICH for Pharma and GHTF/IMDRF for Medical Devices and IVDs
  • Quality System and Risk Management requirements for Pharma, Medical Devices, and IVDs
  • Requirement comparisons between the E.U., U.S., and other countries
  • Comparisons of FDA/cGMP/Q10, ISO 13485/Q10, ISO 14971/Q9
  • Review of ISO, MedDev and EURDALEX

Key Factors of Risk Management

  • Understanding the terms and their relationships: Risk Assessment, Mitigation, Residual Risk, Risk Management
  • Real world examples and exercises reviewing: Harm, Likelihood, Severity
  • Considerations for determining Acceptable Risk

The Risk Management Process

  • Understanding Risk Management and the Product Life Cycle
  • The Pharma approach
  • The Medical Device/IVD approach
  • The common elements and the differences
  • What about “Detectability”?
  • Hazards leading to Harm
  • Introduction to key tools
  • Lessons Learned from the real world
  • Top level integration with the QMS
  • The importance of the Risk/Benefit analysis

Second Day

Focus on tools and their application

  • Key IEC standards
  • Importance of Usability and Operability
  • Risk tables and FMEA: analysis of examples

Workshop Session I

Participants are divided into two groups and are presented with a combo-product description. An Initial Risk Assessment (IRA) is performed by each group: one assesses the pharma component; the other assesses the device component. Each group presents their results then the combined assessment is discussed.

Deeper Dive into Product Life Cycle and Risk Management

  • Product Life Cycle stages
  • Comparison between Pharma and Devices and identification of difference
  • Product Life Cycle and Risk Management
  • Comparing Risk Assessment with clinical experience: The importance of trending

Real World Risk Management Integration into the QMS

  • Medical Device and the Significance of EN ISO 13485:2016 (released March 2016)
  • Pharma and 210/211, Q8, Q9 Q10
  • Review of the QMS elements and examples of integration
  • The importance of risk control effort being proportional to the significance of risk
  • Preconception, misinterpretation: Their potential impact on Calculating Risk

Implementing Risk Management Integration

  • Identifying and overcoming the obstacles and pitfalls
  • How to start

Workshop Session II

Part 1: Participants will select a QMS element and complete an initial Risk Assessment. Results will be shared and discussed by the group.

Introduction to a Wider Application of Risk Management Principals

  • Types of “Risk”
  • Other Management System standards
  • ISO 31000 and the impact of redefining ‘Risk’

Part 2: Using a selected QMS element participants identify an associated Business Objective and complete an initial Risk Assessment using ISO 31000 concepts. Results are shared and discussed by the group.


  • Day 1 Summary
  • Day 2 Summary
  • Final Q&A
  • Meeting Objectives: Assessment of the Course
  • Close

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:

  • Understanding the principals of Risk Management, the terms and their relationships
  • Know the key Risk Management and Quality Management System regulations, requirements, standards, and guidances
  • Understanding similarities and differences between Devices, Pharma, and IVDs relating to QMS and RM requirements
  • Appreciate the importance being current with Quality System and Risk Management regulations and standards
  • Understand the role and contribution of key harmonization groups
  • Develop a working knowledge of tools used in Risk Management
  • Appreciate the significance of Product Life Cycle considerations
  • Develop an understanding of how to integrate RM principals into a QMS
  • Appreciate the potential for wider application of RM principals to general business practices



"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