Category: Validation

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Develop a Strategy to Transition to Paperless Validation C&Q

Presented by: Philip Jarvis, Director, Integrated C&Q and Paperless Strategy, Veqtor & Mark Geldard, Director Sales EMEA, Kneat• Discuss how to develop ROI and momentum for a transition to paperless C&Q• How to influence key stakeholders, and build a culture of digital transformation • Key watch outs and learnings including:o Education on digital execution for flawless […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: ADDRESSING UNCERTAINTY

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 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: DETERMINING THE LEVEL OF FORMALITY

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 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: 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 DublinThe 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 to […]

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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 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 […]

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  • Email: info@kenx.org
  • Phone: 858 649 3251
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