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Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
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Book Description
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.
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
Get Book
Book Description
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.
Author: Richard Whelan
Publisher: U of Nebraska Press
ISBN: 9780803297609
Category : Photography
Languages : en
Pages : 380
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Book Description
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.
Author: Cornell Capa
Publisher:
ISBN: 9780971276505
Category : Documentary photography
Languages : en
Pages : 0
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Book Description
Cornell Capa the photographer has long been overshadowed by Cornell Capa the founder and director of the International Center of Photography, New York, and by Cornell Capa the brother of Robert Capa. This beautiful cloth-bound book, filled with 27 of his most intelligent, compassionate, formally striking images, promises to bring the photographer his due. He once told Camera magazine, "Single photographs are not what I do best. My most effective work is groups of photographs which hang together and tell stories." Nevertheless, the pictures included here sum up and transcend those stories. Imbued with the very essence of the specifics they portray, yet simultaneously resonant with universal human experience, they mark Cornell Capa as what he called "a concerned photographer."
Author: Robert Capa
Publisher: Pickle Partners Publishing
ISBN: 1786256401
Category : History
Languages : en
Pages : 187
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Book Description
In 1942, a dashing young man who liked nothing so much as a heated game of poker, a good bottle of scotch, and the company of a pretty girl hopped a merchant ship to England. He was Robert Capa, the brilliant and daring photojournalist, and Collier’s magazine had put him on assignment to photograph the war raging in Europe. In these pages, Capa recounts his terrifying journey through the darkest battles of World War II and shares his memories of the men and women of the Allied forces who befriended, amused, and captivated him along the way. His photographs are masterpieces — John G. Morris, Magnum Photos’ first executive editor, called Capa “the century’s greatest battlefield photographer” — and his writing is by turns riotously funny and deeply moving. From Sicily to London, Normandy to Algiers, Capa experienced some of the most trying conditions imaginable, yet his compassion and wit shine on every page of this book. Charming and profound, Slightly Out of Focus is a marvelous memoir told in words and pictures by an extraordinary man.—Print Ed.
Author: John Steinbeck
Publisher: Penguin
ISBN: 1440657505
Category : Travel
Languages : en
Pages : 257
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Book Description
Steinbeck and Capa’s account of their journey through Cold War Russia is a classic piece of reportage and travel writing. A Penguin Classic Just after the Iron Curtain fell on Eastern Europe, Pulitzer Prize-winning author John Steinbeck and acclaimed war photographer Robert Capa ventured into the Soviet Union to report for the New York Herald Tribune. This rare opportunity took the famous travelers not only to Moscow and Stalingrad – now Volgograd – but through the countryside of the Ukraine and the Caucasus. Hailed by the New York Times as "superb" when it first appeared in 1948, A Russian Journal is the distillation of their journey and remains a remarkable memoir and unique historical document. What they saw and movingly recorded in words and on film was what Steinbeck called "the great other side there … the private life of the Russian people." Unlike other Western reporting about Russia at the time, A Russian Journal is free of ideological obsessions. Rather, Steinbeck and Capa recorded the grim realities of factory workers, government clerks, and peasants, as they emerged from the rubble of World War II—represented here in Capa’s stirring photographs alongside Steinbeck’s masterful prose. Through it all, we are given intimate glimpses of two artists at the height of their powers, answering their need to document human struggle. This edition features an introduction by Steinbeck scholar Susan Shillinglaw. For more than seventy years, Penguin has been the leading publisher of classic literature in the English-speaking world. With more than 1,700 titles, Penguin Classics represents a global bookshelf of the best works throughout history and across genres and disciplines. Readers trust the series to provide authoritative texts enhanced by introductions and notes by distinguished scholars and contemporary authors, as well as up-to-date translations by award-winning translators.
Author: Marc Aronson
Publisher: Macmillan + ORM
ISBN: 1250109671
Category : Young Adult Nonfiction
Languages : en
Pages : 610
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Book Description
“If your pictures aren’t good enough, you aren’t close enough.” –Robert Capa Robert Capa and Gerda Taro were young Jewish refugees, idealistic and in love. As photographers in the 1930s, they set off to capture their generation's most important struggle—the fight against fascism. Among the first to depict modern warfare, Capa, Taro, and their friend Chim took powerful photographs of the Spanish Civil War that went straight from the action to news magazines. They brought a human face to war with their iconic shots of a loving couple resting, a wary orphan, and, always, more and more refugees—people driven from their homes by bombs, guns, and planes. Today, our screens are flooded with images from around the world. But Capa and Taro were pioneers, bringing home the crises and dramas of their time—and helping give birth to the idea of bearing witness through technology. With a cast of characters ranging from Langston Hughes and George Orwell to Pablo Picasso and Ernest Hemingway, and packed with dramatic photos, posters, and cinematic magazine layouts, here is Capa and Taro’s riveting, tragic, and ultimately inspiring story. This thoroughly-researched and documented book can be worked into multiple aspects of the common core curriculum.
Author: Jane Rogoyska
Publisher: Random House UK
ISBN: 9780224097130
Category : Biographie
Languages : en
Pages : 0
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Book Description
A reexamination of the woman who created the legend of Robert Capa, the world'sfirst female photojournalist to die in combat, Gerda Taro In Paris in 1934, a young and beautiful Jewish émigrée, Gerda Pohorylles, met a Hungarian political exile, André Friedmann. They reinvented themselves as the photographers Gerda Taro and Robert Capa--and he would become the most important photojournalist of his generation. When Gerda was killed in the Spanish Civil war at the age of 26, Robert Capa was her most notable mourner--his grief was beyond control. Her funeral drew crowds of thousands and she became a hero of the political left. Despite the legend that was built around her, she subsequently became a mere footnote in Capa's story. Seventy years after her death a long-lost suitcase was discovered in Mexico, containing thousands of negatives by Capa and Taro. Most astonishingly of all, the "Mexican suitcase" showed that photographs that had been attributed previously to Capa were, in fact, the work of Taro. Jane Rogoyska's book will trace Taro's life and reveal the depth of her relationship with Capa. Charismatic and extraordinary, they epitomized one of the most tumultuous periods of the century.
Author: Cynthia Young
Publisher: Prestel
ISBN: 9783791353500
Category : PHOTOGRAPHY
Languages : en
Pages : 0
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Book Description
This text looks at Robert Capa's colour photography, a little-known but important aspect of the great photographer's work, and includes many never-before-published images. Capa regularly used colour film from the 1940s until his death in 1954. Some of these photographs were published in magazines of the day, but the majority have never been printed, seen, or even studied. "Capa in Color" presents this work an integral part of his post-war career and fundamental in remaining relevant to magazines.
Author: Robert Capa
Publisher: Damiani Limited
ISBN: 9788862087179
Category : Photography
Languages : en
Pages : 112
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Book Description
Once a cult-status rarity, Capa's classic, impassioned Spanish Civil War photobook is available again with new, high-quality image scans and supplementary research Robert Capa's Death in the Making was published in 1938 as a poignant tribute to the men and women, civilians and soldiers alike, fighting in Spain against Franco's fascist insurrection. The book included only one year of images from the Republican position, but covered the spectrum of emotions of a civil war, from the initial excitement to the more harrowing realities of modern warfare. But over time, after World War II and rising anti-communist paranoia in the United States, association with the Spanish Civil War was a liability and the book became obscured. Today, however, Death in the Making has reached cult status, not least because copies are hard to find (particularly ones with Capa's famous Falling Soldier image on the dust jacket). With new scans of all the images, this facsimile of the original edition reproduces the original layout by photographer André Kertész, the original caption text by Capa and preface by writer Jay Allen. The muddy 1938 publication is entirely transformed by high-quality printing to reflect the beauty and pathos of the original intention. This edition also includes a new essay with new research on the making and the reception of the original book, and a complete checklist identifying the author, location and date of each image. The most important new information is that Robert Capa and Gerda Taro are not the only photographers in the book, but also included was work by their good friend and colleague Chim, later known as David Seymour. Born Endre Erno Friedmann in Budapest, Robert Capa (1913-54) spent his early years moving from Hungary to Germany to France and Spain, first to dodge political strife and then to actively follow and document it. From 1936 to 1945 Capa photographed the Spanish Civil War, the Second Sino-Japanese War and World War II. In 1947, he founded the Magnum Photos agency with fellow photographers Henri Cartier-Bresson and David "Chim" Seymour, among others. Several years later, while documenting the First Indochina War, Capa died when he stepped on a landmine.
Author: J Rodriguez
Publisher: Elsevier
ISBN: 1908818379
Category : Medical
Languages : en
Pages : 250
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Book Description
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
