Category: Product Complaints & Adverse Events

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Design an Effective Product Recall and Withdrawal Strategy

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 […]

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Implement an Effective CAPA Management System to Ensure Accurate and Compliant Product Investigations

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 […]

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Developing Robust Adverse Events Risk Management Processes and Execution

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 […]

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Design an Effective Product Recall and Withdrawal Strategy

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 […]

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Product Complaints – Is It Really That Bad? Finding The Right Approach

Presented by Yarismar Fernández-Alicea, Quality Assurance Specialist, Amgen PR Top Reasons to Attend:• Identify different approaches when handling product complaints• Understand the concept of product complaints as an improvement guidance• How to increase efficiency while decrease complexity – The “Discipline of Coming Back to the Basics”• Understand the advantages of standardization when handling product complaints• […]

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