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202201 Medcon Art Direction

MedCon 2022 Workshop


Risk Management: How to Make Validations and Risk Analysis More Robust


Learn effective risk management strategies from an exceptional panel of experts who are rich in industry and FDA experience.

You will learn how to take a total lifecycle approach to risk management by walking through a comprehensive case study throughout the day. You will learn from your peers by being immersed in multiple exercises and engaged in group discussions. The facilitators will share industry pain points and successful practices throughout the workshop:

  • Setting the stage:
    • Global Regulatory Overview
    • 14971:2019 Basics and Definitions 
  • Planning Requirements 
  • Risk Management Activities for Design Inputs and Outputs
  • Verification and Validation Activities
  • Strategy for Design Transfer and Post-Market Surveillance

Workshop Facilitators

Edwin Bills
ASQ Fellow, RAC, Principal Consultant, Edwin Bills Consultant

Bill Brodbeck
Senior Director, Regulatory Affairs, STERIS Corporation

Shannon Hoste
President, Agilis Consulting Group

Kim Trautman
Medical Device, IVD, and Combination Product Regulatory & Quality Expert

In 2022, this conference was co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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