{ "item_title" : "Quality Risk Management in the FDA-Regulated Industry", "item_author" : [" Jose (Pepe) Rodriguez-Perez "], "item_description" : "Risk-based thinking and processes are increasingly important for all organizations, including those regulated by the FDA. This book is an essential guide to a systematic and comprehensive approach to quality risk management. The revised content in this third edition offers an updated view of the risk management field as it applies to FDA-regulated products: how to integrate risk management principles and activities into an existing QMS, remain in compliance with ISO 9001:2015 and ISO 13485:2016, and integrate three key and recently updated guidelines [ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018]. Also includes practical explanations and plenty of helpful case studies and examples-- Provided by publisher. ", "item_img_path" : "https://covers3.booksamillion.com/covers/bam/1/63/694/155/1636941559_b.jpg", "price_data" : { "retail_price" : "70.00", "online_price" : "70.00", "our_price" : "70.00", "club_price" : "70.00", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }

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