Created by: Kimberly Wallbank & Nicole Damour Product complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This […]
Created by: Chris Gray, Principal Consultant, CAI Your company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers […]
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 […]
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