Download or read book Agent Gxp FDA Part 11 Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005-07 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Agent Gxp Fda Part 11 written by Daniel Farb, Bruce Gordon and published by Universityofhealthcare. This book was released on 2004-06-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Agent Gxp Fda Part 11 written by University of Health Care and published by Universityofhealthcare. This book was released on 2003-10-01 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Part 11 and Computer Validation Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Agent GCP and the Bloody Consent Form Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Part 11 and Computer Validation Manual and CD written by Daniel Farb and published by University of Health Care. This book was released on 2003-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a package of Agent GXP FDA Part 11 and Pharmaceutica Computer Validation Introduction. These two related courses will give the learner an excellent introduction to computer isues in the pharmaceutical industry. This course will teach you the history, applications, regulations, implementation, ideas and how to prepare Part 11.
Download or read book Collaborative Process Automation Systems written by Martin Hollender and published by ISA. This book was released on 2010 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Powerful Medical Device Sales Guidebook written by Susan Postnikoff and published by UniversityOfHealthCare. This book was released on 2005-08 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Part 11 and Computer Validation written by Daniel Farb, M. D. and published by Universityofhealthcare. This book was released on 2004-06-01 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a package of Agent GXP FDA Part 11 and Pharmaceutical Computer Validation Introduction. These two related courses will give the learner an excellent introduction to computer issues in the pharmaceutical industry. 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. When you successfully complete the exam, you will receive a certificate of completion that will demonstrate your mastery of this topic and provide documentation of GMP training. Estimated time: 3-6 hours. Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. When you successfully complete the exam, you will receive a certificate of completion to document your training for the FDA or for employers. Estimated time: 2-3 hours. Both courses are 402 pages on CD. 224 pages in the manual include handy printouts of many relevant FDA regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2024-07-03 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.
Download or read book Data Integrity and Compliance written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2019-05-08 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book International IT Regulations and Compliance written by Siri H. Segalstad and published by John Wiley & Sons. This book was released on 2008-11-20 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Guide to Cell Therapy GxP written by Joaquim Vives and published by Academic Press. This book was released on 2015-07-24 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards
