Agent Gxp Fda Part 11 Guidebook
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| Author | : Daniel Farb |
| Publisher | : UniversityOfHealthCare |
| Total Pages | : 221 |
| Release | : 2005-07 |
| Genre | : Medical |
| ISBN | : 1594912734 |
Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course will teach you the history of Part 11, the regulations of Part 11, the implementation of Part 11, the applications of Part 11, the ideas behind Part 11 in order to apply them to new situations, and how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. Readers will enjoy the approachable, compact, conversational style of the title. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version. This is part of the highly acclaimed UniversityOfHealthCare series on FDA regulations.
| Author | : Daniel Farb |
| Publisher | : UniversityOfHealthCare |
| Total Pages | : 329 |
| Release | : 2005 |
| Genre | : Computer security |
| ISBN | : 1594912602 |
Gives an introduction to computer issues in the pharmaceutical industry, as well as to computer systems validation. This work helps you learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and more. It is useful for research personnel in FDA-regulated industries.
| Author | : Daniel Farb |
| Publisher | : UniversityOfHealthCare |
| Total Pages | : 337 |
| Release | : 2005 |
| Genre | : Medical |
| ISBN | : 1594912785 |
Agent GCP is THE way to learn FDA regulations. The exciting, suspenseful, and sometimes zany plot of a murder in a clinical trial is interweaved with interactivity and teaching of FDA regulations in an unforgettable manner. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)—that is, Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for any person or organization participating in clinical trials. The book contains useful aids including a glossary, a list of resources, model consent forms, and texts of regulations. Those readers who wish to have an accompanying program with interactivity should also purchase the CD version.
| Author | : Martin Hollender |
| Publisher | : ISA |
| Total Pages | : 421 |
| Release | : 2010 |
| Genre | : Technology & Engineering |
| ISBN | : 193600710X |
Providing a comprehensive overview of the state-of-the-art in Collaborative Process Automation Systems (CPAS), this book discusses topics such as engineering, security, enterprise connectivity, advanced process control, plant asset management, and operator efficiency. Collaborating with other industry experts, the author covers the system architecture and infrastructure required for a CPAS, as well as important standards like OPC and the ISA-95 series of standards. This in-depth reference focuses on the differences between a CPAS and traditional automation systems. Implications on modern automation systems are outlined in theory and practice. This book is ideal for industrial engineers, as well as graduate students in control and automation.
| Author | : Susan Postnikoff |
| Publisher | : UniversityOfHealthCare |
| Total Pages | : 131 |
| Release | : 2005-08 |
| Genre | : |
| ISBN | : 1594912645 |
A guide for the medical device and pharmaceutical sales representative on sales skills to use with doctors and hospitals while observing correct procedures and building trust. It covers the structure of a hospital, medical staff, the hospital pharmacy, hospital-based pharmacist, the nursing service, policies and procedures for hospital vendors.
| Author | : Orlando Lopez |
| Publisher | : CRC Press |
| Total Pages | : 262 |
| Release | : 2015-04-06 |
| Genre | : Business & Economics |
| ISBN | : 1040083706 |
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
| Author | : Orlando Lopez |
| Publisher | : CRC Press |
| Total Pages | : 268 |
| Release | : 2016-11-03 |
| Genre | : Business & Economics |
| ISBN | : 1315349973 |
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.
| Author | : José Rodríguez-Pérez |
| Publisher | : Quality Press |
| Total Pages | : 137 |
| Release | : 2019-05-08 |
| Genre | : Business & Economics |
| ISBN | : 0873899873 |
Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectationits 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 sourcesincluding the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agencyinto 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.
| Author | : Guy Wingate |
| Publisher | : CRC Press |
| Total Pages | : 773 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420088955 |
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
| Author | : Siri H. Segalstad |
| Publisher | : John Wiley & Sons |
| Total Pages | : 338 |
| Release | : 2008-11-20 |
| Genre | : Law |
| ISBN | : 9780470721834 |
Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.
