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 Recovery Some examples of Product Recall How do Recalls affect a […]
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 and […]
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 decision […]
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 Recovery Some examples of Product Recall How do Recalls affect a […]
Authors:Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies toaddress the challenges and opportunities of implementing science and risk-based decision making andmanufacturing approaches. Since its inception, the PRST has continued to progress research on […]
