Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products: One and a Half Day In-Person Seminar

By: Stan Mastrangelo, Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards
Location :- Tampa, FL | Thursday, February 7, 2019 | Friday, February 8, 2019

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Course Description:

Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas.

Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.

What is the difference between Compliance Risk Management and Product Risk Management? What about acceptability criteria for Compliance Risk Management? Should we merge the Compliance Risk Management activities into the existing Risk Management for Products? What are the expectations for managing risk in Pharmaceuticals (cGMP)? How does the evolving landscape of Compliance Risk Management interface with the evolving landscape of Combination Products?

In this workshop, you will learn how to implement effective Compliance Risk Management in your organization. It is important that key personnel understand what a successful implementation of both ERM and Product Risk Management (ISO 14971) looks like. There are existing tools that may be adapted to implement the new requirements efficiently.

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:

  • What is the difference between Compliance Risk Management and Product Risk Management?
  • What about acceptability criteria for Compliance Risk Management? should we merge the Compliance Risk Management activities into the existing Risk Management for Products?
  • What are the expectations for managing risk in Pharmaceuticals (cGMP)?
  • How does the evolving landscape of Compliance Risk Management interface with the evolving landscape of Combination Products?

Learning Objectives:

Upon completing this course participants should:

  • Read and understand what the expectations are for manufacturers of Medical Devices, Pharmaceuticals, and Combination Products that will be regulated by ISO 13485.
  • Understand how to utilize a risk-based approach to addressing Compliance Risk Management requirements.
  • Evaluate the effectiveness of Risk Management for Compliance and Product (ISO 14971)
  • Develop appropriate Acceptability Criteria for Product and Compliance Risk Management
  • Discriminate between the expectations of Medical Devices, Pharmaceuticals, and Combination Products
  • Implement new or revised tools for improving Risk Management outcomes, both audit and field performance

Who will Benefit:

Risk Management is often a shared responsibility between multiple functions in an organization. Risk Managers may be defined by Job Title, or simply by operational function. Quality Managers will benefit greatly from this course due to their role in defining and defending the compliance aspects of these activities. R&D and Engineering will benefit due to their responsibility as Product Stewards. These functions must understand the implications of their actions with respect to overall product residual risk. Other functions include:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers and managers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists

Course Outline

Day One (8:30 AM – 4:30 PM)
  • Registration Process: 8:30 AM
    • Introduction to Risk Management
      • Pharmaceuticals
      • Combination Products
      • Medical Devices
      • Common Elements
    • What is the Difference Between Risk Management and Risk Science and Why Is It Important?
      • Risk Science Supports Risk Management
      • The Confusion and the consequences
    • Pharmaceutical Risk Management
      • Discussion of Current Expectations
      • Integrating into Quality System
      • Techniques to tie the Islands of Excellence Together
    • Medical Device Risk Management
      • Discussion of Current Expectations
      • AAMI White Paper and Z Annexes to ISO 14971
      • Expanding Beyond Just FMEA
    • Combination Products
      • Review of Guidance Documents for Risk Management Considerations
      • Integrating Key Elements of Both Pharmaceuticals and Devices
    • Enterprise Risk Management and ISO 31000
      • International Standard
    • ISO 90001 has changed the Paradigm
      • The New Concept of “Risk-Based Thinking”
      • What is changing for all industry?
    • What Is Compliance Risk Management?
      • Compliance Risk Management is the bridge to ISO 90001
      • Compliance Risk Management has a different objective
      • What are we going to have to do differently and when?
    • Do I Have to Implement Compliance Risk Management and When?
      • Discussion of Pro’s and Con’s
      • Methods for Documentation
      • Relationship to existing Quality Risk Management
    • How to Prepare for Compliance Risk Management
      • Establishing Process Owner
      • Establishing Objective Acceptability Criteria
      • Integrating into Quality System
    Day Two (8:30 AM – 4:30 PM)
    • Acceptability Criteria – Do’s and Dont’s
      • Product Risk Management
      • Compliance Risk Management
    • The Master Document
      • Advantages of a Trace Matrix Approach
      • Segmentation of the Risk Management File
    • Integration Considerations
      • Audits – Internal and External
      • Documentation is key to a successful program
    • Risk Management and Operational Excellence
      • The Concept of Positive Risk as Opportunity
      • Cost Reductions
      • Documentation Justifications
    • Benchmarking for the Future
      • Discussion of Future Trends in Risk Management
      • Turning Risk Management into a Strategic Advantage
    • Q & A

    Meet Your Instructor

    Stan-Mastrangelo-90X112
    Stan Mastrangelo
    Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards

    Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

    Location :
    Tampa, FL
    (Venue to be announced shortly)

    February 7-8, 2019
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    $1,499

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    February 7-8, 2019, Tampa, FL

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