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November 12, 2014

FoREMS & More: ABCs of FMEA: A Straightforward Approach to Achieving the Standardization of Risk Management Objectives of Regulators

FDA’s recent report on “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)” cites nine categories of feedback they received from stakeholders as strategies to achieve their standardization goals.  One category states, “FDA should adopt and use a more standardized, systematic approach to REMS design, including using human factors evaluation methods like Failure Mode and Effects Analysis (FMEA).”  This webinar evaluates the value of using FMEA for REMS design and offers a step-by-step description of how to use the methodology.

This webinar will highlight:

  • An overview of recommendations for FDA to adopt FMEA for REMS design from groups such as the Brookings Institution
  • Stepwise description of how to use FMEA in REMS or RMP risk minimization design
  • Lessons learned and best practices
  • Discussion of the utility and value of the methodology


  • Marc DeLuca, MHSEng – Associate Director, Clinical Consulting, ParagonRx
  • M. Kris Srinivasan, MD, MBA, MHSEng – Director, Clinical Consulting, ParagonRx


  • For more information on the FDA report: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies, you may view a webinar on the topic here.
  • For a copy of the report, click here.

To view the slides presented during this webinar click here.

To view the recording from this webinar click here.

To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email