Presented by: Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnostics • Introduction to Risk Management according to ISO 14971• Development of a complaint handling process including inter-connections with Risk Management using IM What is a Product Recall?Recall v/s Market Withdrawal v/s Stock RecoverySome examples of Product RecallHow do Recalls affect a Company?Recall Classification […]

Presented by: Sameer Kadam, Expert Solutions Engineer, Sparta Systems, A Honeywell Company · Understand what goes into the Corrective and Preventive Action (CAPA) process· Learn how to conduct an effective root cause analysis using AI tools· Get an in-depth overview on the recall process, including linking to CAPA and product dataTakeaway Tools• Root Cause eBook […]

Presented by: Taylor Dieringer, Risk Management Quality Engineer, iRythmn • Introduction to Risk Management according to ISO 14971• Development of a complaint handling process including inter-connections with Risk Management using IMDRF Codes• Review of complaint trending methodology as pertains to Risk Management• Present ideas related to increasing efficiency in the complaint handling process for timely […]

Presented by: Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnostics • Introduction to Risk Management according to ISO 14971• Development of a complaint handling process including inter-connections with Risk Management using IM What is a Product Recall?Recall v/s Market Withdrawal v/s Stock RecoverySome examples of Product RecallHow do Recalls affect a Company?Recall Classification […]