Category: Validation

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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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State of Validation & Transformational Trends

Presented by: Nathan Temple, Global Director C&Q, CAI Learn about key initiatives, industry drivers and trends that are transforming project delivery with a focus on operational readiness and speed to patient. Project delivery timelines continue to be scrutinized and there are powerful ways to shift validation off the critical path. More importantly, through Quality Risk […]

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Women Leading Validation: Moving The Needle – Quality Panel

Presented by: Dori Gonzalez-Acevedo – CEO and co-founder at ProcellaRX & fellow Chief members:•    Denise Dajles – Senior VP of R&D, Regulatory and Quality at Sientra•    Catherine Hall – VP of Clinical Innovation and Quality at EndPoint Clinical•    Elena Mack – VP, Global Manufacturing Quality, Olympus Corporation•    Dinamarie Stefani – Head […]

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