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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: DETERMINING THE LEVEL OF FORMALITY

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: A CASE FOR RISK DECISION REVIEW POINTS (KDRPS) IN THE QUALITY RISK MANAGEMENT PROCESS

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has continued […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: INSIGHTS FROM OTHER INDUSTRIES

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin The 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 […]

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Role-based Talent Planning for Operational Readiness

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 […]

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High Stakes Change Management: Remediation Post FDA Warning Letter

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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