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 […]
This paper intends to provide guidance on talent planning, with specific emphasis on role clarity. Given the flurry of activity being conducted during capital projects and transitions to operations, developing a talent plan may appear to be somewhat administrative or insufficiently urgent. This often leads site leaders to forego a focused and thoughtful talent planning […]
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 between 30-50% (Adam & Danaparamita, 2016; Beer […]
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