Data Integrity In Pharmaceutical And Medical Devices Regulation Operations PDF Download

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations PDF
Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1315349973
Size: 41.26 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 372
View: 3129

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Data Integrity In Pharmaceutical And Medical Devices Regulation Operations Book Description:

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

Data Integrity And Compliance PDF Download

Data Integrity and Compliance PDF
Author: José Rodríguez-Pérez
Publisher: Quality Press
ISBN: 0873899873
Size: 49.23 MB
Format: PDF, ePub
Category : Business & Economics
Languages : en
Pages : 273
View: 5348

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Data Integrity And Compliance Book Description:

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation—it’s a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources—including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency—into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies’ position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Ensuring The Integrity Of Electronic Health Records PDF Download

Ensuring the Integrity of Electronic Health Records PDF
Author: Orlando López
Publisher: CRC Press
ISBN: 1000222993
Size: 78.33 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : en
Pages : 320
View: 7150

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Ensuring The Integrity Of Electronic Health Records Book Description:

Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Medical Product Regulatory Affairs PDF Download

Medical Product Regulatory Affairs PDF
Author: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 9783527318773
Size: 57.38 MB
Format: PDF
Category : Science
Languages : en
Pages : 297
View: 6641

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Medical Product Regulatory Affairs Book Description:

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Biotechnology Operations PDF Download

Biotechnology Operations PDF
Author: John M. Centanni
Publisher: CRC Press
ISBN: 149875886X
Size: 28.38 MB
Format: PDF, ePub, Mobi
Category : Medical
Languages : en
Pages : 476
View: 5362

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Biotechnology Operations Book Description:

This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation PDF Download

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation PDF
Author: Orlando Lopez
Publisher: Taylor & Francis
ISBN: 1351704346
Size: 78.10 MB
Format: PDF, ePub, Mobi
Category : Business & Economics
Languages : en
Pages : 326
View: 7661

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Pharmaceutical And Medical Devices Manufacturing Computer Systems Validation Book Description:

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

The Role Of The Study Director In Nonclinical Studies PDF Download

The Role of the Study Director in Nonclinical Studies PDF
Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 1118874080
Size: 49.61 MB
Format: PDF, Mobi
Category : Science
Languages : en
Pages : 560
View: 2698

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The Role Of The Study Director In Nonclinical Studies Book Description:

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Bioengineering PDF Download

Bioengineering PDF
Author: Igor Paul
Publisher: Elsevier
ISBN: 1483139441
Size: 67.78 MB
Format: PDF, ePub, Mobi
Category : Health & Fitness
Languages : en
Pages : 548
View: 715

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Bioengineering Book Description:

Bioengineering: Proceedings of the Eighth Northeast Conference focuses on the discussion of scientific programs, methodologies, experiments, and contributions to the advancement of bioengineering, such as in the field of medicine. The book is composed of literature of various authors who have worked diligently in the field of bioengineering. The text starts by discussing the conditions, situations, and experiments on how the human bones and other internal organs react if subjected to stress, fatigue, and other factors. The properties, composition, and reactions of these body parts to different conditions are discussed. Experiments on regional tissue blood flow through hydrogen clearance and on minimizing the effect of gas trapping on static pressure-volume curves of excised lungs are also presented. The book also notes the instrumentation and control systems for clinical vestibular and cardiovascular stress testing. A large part of the selection deals with research on different internal body parts when subjected to different conditions. Supporting these discussions are control measures, findings, suggestions, methodologies, numerical representations, and recommendations. The book is valuable to scholars, researchers, and readers who are interested in the field of bioengineering.

Handbook Of Computer And Computerized System Validation For The Pharmaceutical Industry PDF Download

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry PDF
Author: Stephen Robert Goldman
Publisher: AuthorHouse
Size: 28.48 MB
Format: PDF, ePub, Mobi
Category : Computers
Languages : en
Pages : 472
View: 4414

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Handbook Of Computer And Computerized System Validation For The Pharmaceutical Industry Book Description:

The Curse is a tale of horror and suspense. It tells the story of a group of common people fleeing from their daunting past, and their struggle for survival. It shows how man's evil transgression and guilty conscience will literally follow him to his death, and perhaps even cause it. It also tells of how one man's fault could not only lead to his suffering, but also to those he holds dear. The tale begins when a group of six daring, young teenage boys plan an upcoming Halloween prank. The mastermind of the six, Jack Boomer, decides to try something different and more dangerous than the previous years. He plans to blow up the shack with a pile of firecrackers. Four of his cronies immediately agree with his plan; however, Ted Dot, the pessimistic, redheaded teenager, is reluctant. He tries to explain to them the consequences of being caught. The other five are not dissuaded from the idea, and they somehow talk Ted into going along with them. Once all six confirm their new idea, they gather their materials. On Halloween night, they set out to execute their plan. Everything works out perfectly for them, and the shack soon erupts into a blazing fury. Their celebration is short-lived, though. From out of the forest appears a mysterious old woman. Her ethnicity is unknown, her origin is unknown, why she is bald, wears a polka-dotted skullcap, wraps her feet in construction paper for shoes, and wears a mud-stained, dark brown dress is all unknown, and it remains unknown throughout the story. The entire time she is simply referred to as the "old woman." In her hand she carries a long, gnarled staff the most significant figure in the entire piece. This stranger claims that the destroyed shack was her home, and she doesn't give the six teenagers a chance to explain. She unleashes her fury and invokes a horrible curse upon them. From then on, it is the ultimate survival story for the six boys. Not only do they suffer the consequences, but also their family members and other best friends are part of the ordeal. And, the "old woman" claims, the terrible conflict does not cease until all six of them have been wiped out.