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LinkedIn Group - Pharmaceutical Operational Excellence
Created: July 14, 2009 | Professional Organization | Members: 1,459
We believe in taking the “whole is greater than the sum of its parts” approach to pharmaceutical manufacturing performance management and wanted to create a platform where pharmaceutical industry professionals could find value in sharing their ideas, opinions & experiences. The Pharmaceutical Operational Excellence (POE) Group is for those professionals dedicated to furthering their personal knowledge base and/or for those committed to maintaining competitive advantage. We welcome your participation – come ask questions, share ideas, get information and explore various possibilities within the arena of POE. This group was founded by Parsec Automation and is managed by Shaun Hendon.
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CAPA and Root Cause Analysis
Recent FDA Warning Letters have cited insufficient corrective and preventive action (CAPA) programs as major compliance weaknesses....
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Essential Elements of Effective CAPA Systems
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Because more than half of Form 483 observations and warning letters cite CAPA deficiencies, it’s evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections....
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