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House documents
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Western Boatman
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HRA, HSA, CDC, OASH, & ADAMHA Public Advisory Committees
Directory of information for public advisory committees and 4 agencies of the Public Health Service directly concerned with health care, health services, and related research activities. Committees are arranged under the offices or agencies, e.g., the National Institute of Mental Health has 30 committees listed thereunder. Each entry gives authority of the committee, structure, function, meetings, and members. Indexes of committees and individuals.
Quality Risk Management in the FDA-Regulated Industry
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is ...
Proceedings
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