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Author: International Validation Forum Publisher: CRC Press ISBN: 9780824794590 Category : Science Languages : en Pages : 1114
Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Author: International Validation Forum Publisher: CRC Press ISBN: 9780824794590 Category : Science Languages : en Pages : 1114
Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Author: International Validation Forum Publisher: CRC Press ISBN: 9780824797461 Category : Science Languages : en Pages : 860
Book Description
This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.
Author: Abhay Bhargav Publisher: CRC Press ISBN: 1439887411 Category : Computers Languages : en Pages : 344
Book Description
Although organizations that store, process, or transmit cardholder information are required to comply with payment card industry standards, most find it extremely challenging to comply with and meet the requirements of these technically rigorous standards. PCI Compliance: The Definitive Guide explains the ins and outs of the payment card industry (
Author: Destin A. LeBlanc Publisher: CRC Press ISBN: 1000835596 Category : Medical Languages : en Pages : 216
Book Description
Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Author: Daniel Farb Publisher: UniversityOfHealthCare ISBN: 1594912629 Category : Medical Languages : en Pages : 116
Book Description
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. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.
Author: David Kim Publisher: Jones & Bartlett Publishers ISBN: 128411645X Category : Computers Languages : en Pages : 571
Book Description
Revised and updated with the latest data in the field, Fundamentals of Information Systems Security, Third Edition provides a comprehensive overview of the essential concepts readers must know as they pursue careers in information systems security. The text opens with a discussion of the new risks, threats, and vulnerabilities associated with the transition to a digital world. Part 2 presents a high level overview of the Security+ Exam and provides students with information as they move toward this certification.
Author: Gupta, Manish Publisher: IGI Global ISBN: 1522526056 Category : Computers Languages : en Pages : 382
Book Description
Attacks on information systems and applications have become more prevalent with new advances in technology. Management of security and quick threat identification have become imperative aspects of technological applications. Information Technology Risk Management and Compliance in Modern Organizations is a pivotal reference source featuring the latest scholarly research on the need for an effective chain of information management and clear principles of information technology governance. Including extensive coverage on a broad range of topics such as compliance programs, data leak prevention, and security architecture, this book is ideally designed for IT professionals, scholars, researchers, and academicians seeking current research on risk management and compliance.
Author: Daniel Farb Publisher: UniversityOfHealthCare ISBN: 1594912602 Category : Computer security Languages : en Pages : 329
Book Description
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: Debra S. Herrmann Publisher: CRC Press ISBN: 1420013289 Category : Business & Economics Languages : en Pages : 848
Book Description
This bookdefines more than 900 metrics measuring compliance with current legislation, resiliency of security controls, and return on investment. It explains what needs to be measured, why and how to measure it, and how to tie security and privacy metrics to business goals and objectives. The metrics are scaled by information sensitivity, asset criticality, and risk; aligned to correspond with different lateral and hierarchical functions; designed with flexible measurement boundaries; and can be implemented individually or in combination. The text includes numerous examples and sample reports and stresses a complete assessment by evaluating physical, personnel, IT, and operational security controls.
Author: Carmen Medina Publisher: CRC Press ISBN: 0824758749 Category : Medical Languages : en Pages : 604
Book Description
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Author: International Validation Forum
Author: International Validation Forum
Author: International Validation Forum
Author: Abhay Bhargav
Author: Destin A. LeBlanc
Author: Daniel Farb
Author: David Kim
Author: Gupta, Manish
Author: Daniel Farb
Author: Debra S. Herrmann
Author: Carmen Medina