Validation Compliance Annual
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Validation Compliance Annual
Author | : International Validation Forum |
Publsiher | : CRC Press |
Total Pages | : 1114 |
Release | : 1995-02-17 |
Genre | : Science |
ISBN | : 0824794591 |
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"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."
Validation Compliance Biannual 1996 1997
Author | : International Validation Forum |
Publsiher | : CRC Press |
Total Pages | : 860 |
Release | : 1996-04-10 |
Genre | : Science |
ISBN | : 0824797469 |
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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.
PCI Compliance
Author | : Abhay Bhargav |
Publsiher | : CRC Press |
Total Pages | : 344 |
Release | : 2014-05-05 |
Genre | : Computers |
ISBN | : 9781439887417 |
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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 (
Pharmaceutical Computer Validation Introduction Guidebook
Author | : Daniel Farb,Bruce Gordon |
Publsiher | : UniversityOfHealthCare |
Total Pages | : 116 |
Release | : 2005 |
Genre | : Medical |
ISBN | : 9781594912627 |
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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.
Fundamentals of Information Systems Security
Author | : David Kim,Michael G. Solomon |
Publsiher | : Jones & Bartlett Publishers |
Total Pages | : 571 |
Release | : 2016-10-15 |
Genre | : Computers |
ISBN | : 9781284116458 |
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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.
Compliance Handbook for Pharmaceuticals Medical Devices and Biologics
Author | : Carmen Medina |
Publsiher | : CRC Press |
Total Pages | : 604 |
Release | : 2003-12-09 |
Genre | : Medical |
ISBN | : 9780824758745 |
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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.
Handbook of Bioequivalence Testing
Author | : Sarfaraz K. Niazi |
Publsiher | : CRC Press |
Total Pages | : 1007 |
Release | : 2014-10-29 |
Genre | : Medical |
ISBN | : 9781482226386 |
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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
Pharmaceutical and Medical Applications of Near Infrared Spectroscopy
Author | : Emil W. Ciurczak,James K. Drennen, III |
Publsiher | : CRC Press |
Total Pages | : 203 |
Release | : 2002-02-08 |
Genre | : Science |
ISBN | : 9780824743253 |
Download Pharmaceutical and Medical Applications of Near Infrared Spectroscopy Book in PDF, Epub and Kindle
This book discusses the theory, instrumentation, validation, and implementation of near-infrared spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug manufacturing process.