Capas
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Dealing With Capa
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Author : Daniela Biddick
language : en
Publisher:
Release Date : 2021-05-21
Dealing With Capa written by Daniela Biddick and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-05-21 with categories.
Experience, training, and sound procedures in your facility may mean that problems rarely arise. But, what about when they do? CAPA, or corrective action and preventive action, can provide a structure for finding the root cause of problems, solving those problems, documenting the conditions and solutions for the future, and looking for potential problems and their solutions. Corrective actions are often used in HR and other manufacturing contexts, but other industries may also be required by the Food and Drug Administration (FDA) to document CAPA processes and then follow the processes if a problem occurs - especially food processing or pharmaceutical and medical device manufacturing. Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: - Information about the importance of the CAPA system within the quality system for the medical products regulated industry. - Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. - Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. - New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. - A new chapter fully devoted to human errors and human factors, and their impact on the investigation and CAPA system. - Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. - An example of an investigation and CAPA expert certification program being used for many companies. - Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format.
Handbook Of Investigation And Effective Capa Systems
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Author : Jose (Pepe) Rodriguez-Perez
language : en
Publisher: Quality Press
Release Date : 2022-02-15
Handbook Of Investigation And Effective Capa Systems written by Jose (Pepe) Rodriguez-Perez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Business & Economics categories.
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Robert Capa
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Author : Richard Whelan
language : en
Publisher:
Release Date : 2001
Robert Capa written by Richard Whelan and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with categories.
Capa In The Pharmaceutical And Biotech Industries
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Author : J Rodriguez
language : en
Publisher: Elsevier
Release Date : 2015-12-08
Capa In The Pharmaceutical And Biotech Industries written by J Rodriguez and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-08 with Medical categories.
CAPA 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. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately
Handbook Of Investigation And Effective Capa Systems Second Edition
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Author : José Rodríguez Pérez
language : en
Publisher:
Release Date : 2016
Handbook Of Investigation And Effective Capa Systems Second Edition written by José Rodríguez Pérez and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Electronic books categories.
Robert Capa 1913 1954
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Author : Robert Capa
language : en
Publisher: Penguin Group
Release Date : 1974
Robert Capa 1913 1954 written by Robert Capa and has been published by Penguin Group this book supported file pdf, txt, epub, kindle and other format this book has been release on 1974 with Biography & Autobiography categories.
"Robert Capa: Photographs is the first true retrospective book of one of the century's greatest photographers. Drawing upon hundreds of previously unseen images, this collection reveals Capa as one of the great poets of the camera. In these photographs, we see through the eyes of a driven humanist who was also a documentarian of the highest caliber. While previous volumes on Capa have focused on his role as a war photographer, "Robert Capa: Photographs shows us the remarkable range of his work, which encompasses the sufferings as well as the tenderness, humor and wonder of his subjects. Robert Capa demonstrated not only a passionate commitment to improving the human condition, but also an unfailing eye for graphic impact. Although his photographs remain the definitive visual records of such momentous events as the siege of Madrid, the bombing of Hankou, and the Allied landings on D-day, many of his images have a timeless and universal quality that transcends the specifics of history. A Spanish soldier recoils at the impact of a bullet, the final instant of his life. In a scene of perfect joy, a group of Chinese children laugh at the sky as snow begins to fall. Four farm workers, hauling all the belongings they can manage, trudge grimly away from an apocalyptic backdrop of smoke and ruins: their war-devastated homes. Capa's images reveal his profound compassion and perceptiveness about our tenuous human state. As Cornell Capa (Robert's younger brother and the Founding Director Emeritus of the International Center of Photography) writes in his eloquent remembrance: "He managed to travel all over the world, and to communicate his experience and feelings through a universallanguage: photography." "Robert Capa: Photographs also includes a foreword by Capa's close friend Henri Cartier-Bresson, as well as an informative historical essay by Capa biographer Richard Whelan. At last, here is the book that reveals Robert Capa in a new light. The extraordinary collection of images in "Robert Capa: Photographs brings us--through the events of history--to the very heart of humanity.
Robert Capa
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Author : Richard Whelan
language : en
Publisher: Phaidon Press
Release Date : 2001-10-10
Robert Capa written by Richard Whelan and has been published by Phaidon Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-10-10 with Photography categories.
This is the first book to reproduce the definitive set of 937 rarely seen and classic images by Robert Capa (1913-54), one of the most influential documentary photographers of the twentieth century. Capa, a founding member of Magnum photographic agency, had the mind of a passionate and committed journalist and the eye of an artist. His lifework, consisting of more than 70,000 negatives, constitutes an unparalleled documentation of a crucial 22-year period (1932-54), encompassing some of the most catastrophic and dramatic events of the last century. This book represents the most definitive selection of Capa's work ever published - 937 photographs meticulously selected by his brother Cornell Capa (himself a noted Lifephotographer), and his biographer, Richard Whelan. The photographs, arranged in chronological order as stories and accompanied by brief commentaries, reveal the dramatic shifts in location and subject matter that Capa experienced from day to day - from war-torn Israel to Pablo Picasso on a sunny beach in France, and from Ernest Hemingway carousing in London to Capa's historic images of the Allied landing on Omaha Beach in Normandy in 1944.
Capa Capa
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Author : Robert Capa
language : en
Publisher:
Release Date : 1992
Capa Capa written by Robert Capa and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Photography, Artistic categories.
Robert Capa Photographs
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Author : Robert Capa
language : en
Publisher:
Release Date : 1996
Robert Capa Photographs written by Robert Capa and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Photography categories.
This work contains 13 chapters demonstrating the extraordinary scope and diversity of the images from two decades that made Robert Capa one of the world's most distinguished photographers.
Robert Capa
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Author : Richard Whelan
language : en
Publisher: U of Nebraska Press
Release Date : 1994-01-01
Robert Capa written by Richard Whelan and has been published by U of Nebraska Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-01-01 with Photography categories.
The legendary war photographer Robert Capa carried into his personal life the same remarkable vitality that characterizes his pictures. Driven from his native Hungary by political oppression, he was first recognized for photographing the Spanish Civil War. In 1938 he was in China recording the Japanese invasion. During World War II he was in London, North Africa, and Italy, and then in France covering D-Day on Omaha Beach, the liberation of Paris, and the Battle of the Bulge. When the new nation of Israel was founded in 1948 he was there. In 1954 he was in Vietnam, taking photographs until the moment he was killed. Away from battle, Capa gather about him such famous people as Ernest Hemingway and his wife (the war correspondent Martha Gellhorn), Gary Cooper, Irwin Shaw, and Gene Kelly. Whelan shows Capa photographing the street life of Paris, crisscrossing America on assignment from Life, in Russia with John Steinbeck, in Italy with John Huston, on the Riviera with Picasso, and with Ingrid Bergman.