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2022 MedCon Workshop

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

Workshop Description

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-AGILIS-2022

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.