Validation Archives - Page 7 of 8

Category: Validation

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Digital Cleaning Validation Lifecycle

Presented by: Rui Almedia, Director, Product Life Cycle Management Services, ValGenesis. Inc.Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how to […]

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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

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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 […]

Category: Validation

Digital Cleaning Validation Lifecycle

Develop a Strategy to Transition to Paperless Validation C&Q

IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: ADDRESSING UNCERTAINTY

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

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

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Modernize Risk Assessments by Using Critical Thinking

Fit for Intended Purpose- Key Concept in USP General Chapters and ICH Guides

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Recommended for you

Modernize Risk Assessments by Using Critical Thinking

Fit for Intended Purpose- Key Concept in USP General Chapters and ICH Guides

Categories

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