{"product_id":"capa-in-the-pharmaceutical-and-biotech-industries-how-to-implement-an-effective-nine-step-program-hardback-9781907568589","title":"CAPA in the Pharmaceutical and Biotech Industries; How to Implement an Effective Nine Step Program (Hardback) 9781907568589","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eCAPA in the Pharmaceutical and Biotech Industries\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eHow to Implement an Effective Nine Step Program\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cem\u003e\u003cp\u003eContains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) using a nine-step, closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as anyone who has to maintain a quality system\u003c\/p\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eJ Rodriguez (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781907568589, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 11 December 2015\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e248 pages\u003cbr\u003e22.9 x 15.1 x 2.1 cm, 0.39 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"...useful for anyone working in quality assurance or regulatory affairs as a reference guide and as a tool for setting up or improving CAPA programmes.\" --\u003cb\u003eThe Pharmacetical Journal\u003c\/b\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003ci\u003e \u003c\/i\u003e\u003cp\u003eCAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cul\u003e \u003cli\u003eStep-by-step basics on how to build a comprehensive CAPA program\u003c\/li\u003e \u003cli\u003eHow to use a nine step CAPA process to effectively handle any product or quality system failures\u003c\/li\u003e \u003cli\u003eHow to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner\u003c\/li\u003e \u003cli\u003eHow to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk\u003c\/li\u003e \u003cli\u003eHow to use Failure Mode and Effect Analysis to identify potential failure modes\u003c\/li\u003e \u003cli\u003eHow to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities\u003c\/li\u003e \u003cli\u003eResponding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions\u003c\/li\u003e \u003cli\u003eEfficient use of root cause analysis tools\u003c\/li\u003e \u003cli\u003eOptimizing CAPA and RCA documentation procedures\u003c\/li\u003e \u003cli\u003eEssential SOPs and other documentation\u003c\/li\u003e \u003cli\u003eReview areas of common FDA’s 483 inspection observations\u003c\/li\u003e \u003cli\u003eHow to effectively identify and track deviations and non-conformances\u003c\/li\u003e \u003cli\u003eLearning to analyze and trend data to identify existing and potential causes of non-conformance\u003c\/li\u003e \u003cli\u003eGathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation\u003c\/li\u003e \u003cli\u003eReview the elements of a good investigation\u003c\/li\u003e \u003cli\u003eIntegrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling\u003c\/li\u003e \u003cli\u003ePerforming trend analysis and using effective RCA tools\u003c\/li\u003e \u003cli\u003eHow to use of statistical methodologies when performing Root Cause Analysis\u003c\/li\u003e \u003cli\u003eCAPA and the linkage to effective management review and annual product reviews\u003c\/li\u003e \u003cli\u003eStep-by-step basics on how to build your own comprehensive CAPA program\u003c\/li\u003e \u003cli\u003eMost important: Review of the real benefits of an effective CAPA system\u003c\/li\u003e\n\u003c\/ul\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmacy \/ dispensing [\u003ca title=\"See our other books on Pharmacy \/ dispensing\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacy%20\/%20dispensing%20%5BMQP%5D%22\"\u003eMQP\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Woodhead Publishing","offers":[{"title":"Default Title","offer_id":46651780595992,"sku":"9781907568589","price":102.65,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9781907568589.jpg?v=1696403896","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/capa-in-the-pharmaceutical-and-biotech-industries-how-to-implement-an-effective-nine-step-program-hardback-9781907568589","provider":"Freshly Printed Books","version":"1.0","type":"link"}