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
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.