ListarManufacturing Engineering por tema "Risk management"
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Applying a Quality Risk Management Approach to a Cleaning Validation System
(Polytechnic University of Puerto Rico, 2014)Cleaning Validation is a crucial step on assuring product effectiveness and safety by assuring that the equipment to be used has the appropriate condition to manufacture a new product without any foreign substances ... -
Quality Risk Management for the Evaluation of Potable Water Final Rinse during the Cleaning Process of Granulator Jilter Bags
(Polytechnic University of Puerto Rico, 2013)The objective of this article is to describe the application of Quality Risk Management (QRM) approach to assess and manage the risk associated to the impact of using Potable Water during the final rinse process used to ... -
Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
(Polytechnic University of Puerto Rico, 2013)In the pharmaceutical industry every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in recent ... -
Quality Risk Management Strategies for Computer Systems Validation
(Polytechnic University of Puerto Rico, 2014)Quality Risk Management is something that has been gaining attention in the regulated industry because it is listed as regulation in various regulatory agencies such as FDA, ICH, ISO, ISPE and other involved regulatory ... -
Smart Camera Mimics Humans Decision Making Process in a Vial Crimp Quality Automated Inspection Process
(Polytechnic University of Puerto Rico, 2013)Crimp quality is an important attribute in the vial filling process. It protects the sterility of the product from manufacturing until it is dispensed. A pharmaceutical company performed a Failure Mode and Effect ...