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Author: International Validation Forum
Publisher: CRC Press
ISBN: 1040280684
Category : Science
Languages : en
Pages : 1114
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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: 1040280684
Category : Science
Languages : en
Pages : 1114
Get Book Here
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: Destin A. LeBlanc
Publisher: CRC Press
ISBN: 1000835596
Category : Medical
Languages : en
Pages : 216
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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: Abhay Bhargav
Publisher: CRC Press
ISBN: 1498759998
Category : Computers
Languages : en
Pages : 331
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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: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1482226383
Category : Medical
Languages : en
Pages : 992
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
Author: Debra S. Herrmann
Publisher: CRC Press
ISBN: 1420013289
Category : Business & Economics
Languages : en
Pages : 848
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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: Neira Jones
Publisher: Taylor & Francis
ISBN: 1003855628
Category : Business & Economics
Languages : en
Pages : 463
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Book Description
This is the book for professionals in the payments industry. Written in an engaging and accessible style, it enables new and experienced payments practitioners alike to understand the fundamentals of the various payment ecosystems, and to quickly get up to speed on developments in the industry. From cards to bank and alternative payments, the jargon is debunked and myths are busted. For each ecosystem, a simple framework is used: mechanics, economics, risks, and future outlook, enabling comparison and the evaluation of the best applications in different scenarios. The book also provides an overview of the global regulatory landscape. Drawing on real examples throughout, it weaves together the underpinning ecosystem principles, legislation, and key stakeholders. It offers readers practical advice regarding, and insights into, the key disciplines and equips them with an understanding of the key issues and opportunities. Also including an extensive and comprehensive glossary of terms – the first of its kind in the payments industry – this book will be used as an essential reference for years to come. Understanding Payments will enable payments practitioners, private sector corporations, and regulators to keep up with a fast-evolving and extremely competitive industry. It can be used across businesses to help train staff and as part of continuing professional development, and will be useful to those involved in mergers and acquisitions, investors wanting to understand the industry, professional services firms, law firms and consultants, and policy makers.
Author: United States. Defense Logistics Agency
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 68
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Book Description
Author: The WBF
Publisher: Momentum Press
ISBN: 1606502050
Category : Technology & Engineering
Languages : en
Pages : 422
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Book Description
THE WBF BOOK SERIES--ISA 88 and ISA 95 In Life Science Industries is a guide book to the ISA 88 and ISA 95 Manufacturing Protocols. The book features: -- How to set up a pharmaceutical module library using ISA 88 and how to implement ISA 88 across life Science Development Operations -- Understanding Product life cycle batches -- Case Studies on Risk-based engineering assessment and qualifications, a SCADA upgrade project, and more. The ISA (International Society of Automation) standards 88 and 95 are manufacturing standards established in the late 1990s and periodically updated by the governing bodies responsible for them -- the ISA and the WBF (World Batch Forum). The two standards set up protocols and uniform specifications for batch control systems, including types of control equipment, design of control systems and interpretation of batch control data. In Volume 1, ISA 88 and 95 are explained in the context of the pharmaceutical and medical industries. Examples of such batch processing procedures as fermentation, separation, and refinement are discussed and how the two standards affect the design of facilities and systems for performing these procedures. The ISA 88 and 95 standards have been around (and periodically updated) for nearly 20 years now, but little really helpful has been published on how to put those standards into use, particularly from a pragmatic, real-life experience point of view. The four books in this new series will do exactly that: explain to the manufacturing engineer, the controls engineers, and the industrial planner and manager alike how these standards translate into improved batch and continuous process operations -- and ultimately how those operations can be integrated and automated into general business operations (accounting, inventory, customer relations, product development) of the manufacturing concern.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
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Book Description
Author:
Publisher:
ISBN:
Category : Meat
Languages : en
Pages : 74
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Book Description
