Improving Risk-Based Decision Effectiveness: A Case For Risk Decision Review Points (KDRPS) In the Quality Risk Management Process

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & 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 […]

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Improving Risk-Based Decision Effectiveness: Determining The Level Of Formality

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & 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 […]

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Improving Risk-Based Decision Effectiveness: Addressing Uncertainty

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & 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 […]

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Cleaning Validation Program Design: Risk-Based Lifecycle Approach

Created by: Matthew Jackson, Validation Manager, Torbay Pharmaceuticals This article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA. KENX-Insight_Matthew-Jackson_Cleaning-Validation-Program-Design_August-2022-1Download

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CIP Cleaning Cycle Development Pitfalls and Solutions

Created by: Fred Ohsiek, Cleaning Validation Expert Developing an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on developing the automated CIP process for a new facility, […]

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