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Applying Risk Management Principles to Drive …

Applying Risk Management Principles to Drive quality Management system effectiveness Carlos Monteagudo Director of quality Assurance Amgen, Inc. PQRI 2nd FDA/PQRI Conference on Advancing Product quality October 6th, 2015. Presentation Agenda Drivers and Basic Principles for Integrating Risk Management into quality Management Systems Examples of Risk Management Integration into quality Management Systems To Drive Efficiency and effectiveness Development quality Defect Investigations Change Control Management Product Complaints Equipment Commissioning and Qualification Supplier Auditing Driving Periodic Continuous Improvement Periodic Reviews and Risk Management 2. Risk Management Enables effectiveness of quality Management Systems quality risk Management is integral to an effective pharmaceutical quality system . It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality .

Applying Risk Management Principles to Drive Quality Management System Effectiveness Carlos Monteagudo Director of Quality Assurance Amgen, Inc. PQRI 2nd FDA/PQRI Conference on Advancing Product Quality

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