Failure Mode and Effects Analysis (FMEA): A Systematic and Defensible Approach to Risk Mitigation For A New Drug Regimen

Time

Wed, Jun 17 9:00AM
W 12

Title

Failure Mode and Effects Analysis (FMEA): A Systematic and Defensible Approach to Risk Mitigation For A New Drug Regimen

Abstract Summary

ORAL PRESENTATION SCHEDULED: Wednesday, June 17 in Session #2A at 10:17 - 10:22 am in the Exhibit Hall Poster Area (Hall A entrance)

A multi-disciplinary team conducted an FMEA to proactively analyze the patient care process and stakeholders involvement. Failure modes that could expose patients to risks were identified and assigned hazard scores based on their severity and occurrence. Targeted interventions were proposed.

Poster Presenter

Anthony Gbadebo Oladipo
Senior Scientific Director, Risk Management, Pharmacovigilance & Patient Safety,
AbbVie Inc
United States