Annotations for Quality Risk Management in the FDA-Regulated Industry

Book News
Rodríguez-Pérez, a quality manager, engineer, and auditor associated with a Puerto Rican training and consulting organization focused on the FDA-regulated industry, offers a systematic approach to quality risk management for FDA-regulated medical and food product manufacturers wanting to integrate a risk management system, principles, and activities into their quality management system. He details the historical background of risk-based concepts and how the initial safety-only focus integrated other elements; what is currently being done in the different areas regulated by the FDA for products like medical devices, food, and drugs; and the main principles of quality risk management, with an emphasis on the scientific basis of the process and its relationship with quality system elements. He describes the quality risk management process, including responsibilities, risk assessment, risk control and communication, and review and evaluation of its effectiveness; the integration of risk management and quality management, with examples of process analytical technology, quality system inspection techniques, and the prioritization of FDA inspection based on risk elements; methodologies and tools used in the process, with examples; and applications. General examples and case studies are provided in appendices, and the CD-ROM contains FDA guidance documents, international harmonization documents, and an exam with answers. Annotation ©2012 Book News, Inc., Portland, OR (