Safety Assurance Cases for Combination Products

Bethesda, MD
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This 2-day course provides attendees with an understanding of safety assurance cases and how they can be applied to combination products to demonstrate safety and facilitate pre-market review communications with the FDA. It covers the elements of assurance cases; the common issues and resolutions related to assurance cases; and the structure templates and approach for using assurance cases to achieve three important goals: to demonstrate safety, to create and review a safety assurance case with good arguments and evidence, and to relate the results to managing risk and improving product safety.

There will be examples and interactive exercises to reinforce learning and allow participants to apply their new knowledge to create and review safety assurance cases and hear feedback from the FDA reviewers. The program also offers the opportunity for the participants to interact with FDA reviewers on questions related to safety assurance cases.


  • A. Course Introduction
  • B. Risk Management and Safety
  • C. Assurance Case Method
  • D. Safety Assurance Case Argument Structure
  • E. Develop Argument on Risk Mitigation Adequacy
  • F. Develop Safety Argument on Verification & Validation Adequacy
  • G. Develop Safety Argument on Reliability Adequacy
  • H. Develop Confidence Argument on Safety Case Effectiveness
  • I. Combination Product Industry Practices of Assurance Cases – Case Study
  • J. Assurance Cases, Risk Management, Safety and Regulatory Science

Who Should Attend

  • Regulatory Affair Professionals
  • Safety/Risk Management Engineers
  • System and R&D Engineers
  • Quality Assurance
  • Management (Managers, Directors, or Senior Management)
  • Industry Consultants
  • 3rd Party Reviewers
  • Patient Safety Advocators
  • Any professionals who are interested to learn about safety assurance case method and its applications to combination products or medical devices.


No previous experience with safety assurance cases is required. A basic understanding of medical device risk management concepts and terminology would be a plus.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain assurance case concepts, principles and terminology
  • Recognize different formats for safety assurance cases and the pros and cons associated
  • Recognize what elements of safety assurance cases that maybe useful to demonstrate safety and facilitate communications with the FDA reviewers during premarket reviews
  • Get answers from FDA on questions related to safety assurance cases for combination products
  • Recognize safety assurance case structure templates for combination products
  • Generate safety assurance case leveraging risk management information
  • Write safety assurance case arguments in detail with appropriate rigor
  • Choose proper safety assurance case evidence
  • Recognize possible limits that may be associated with standard risk management techniques
  • Identify when and how safety assurance case methods enhance risk management
  • Recognize common issues related to assurance cases and resolutions
  • Identify fallacies in safety assurance case arguments
Agenda is subject to change.

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Fubin Wu, President, GessNet™ Risk Management and Assurance Case Consulting

Fubin Wu is the co-founder and president of GessNet™, providing risk management and safety assurance case consulting and software solutions. He has experience in drug delivery combination products, infusion pumps, mobile medical applications, implantable devices and remote monitoring systems, and blood management standalone software devices. Prior to GessNet™, Fubin had spent over 16 years on medical device quality and regulatory affairs, hardware/software reliability engineering and risk management, and served roles from engineers to managers and directors. Fubin has an MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU), and was a software developer at Intel prior to his career in the medical device industry.

Lee Leichter, President, P/L Biomedical

Alan Stevens, Branch Chief, General Hospital Devices Branch, ODE/CDRH, U.S. Food and Drug Administration