Author: Daniel Farb
Edition:
Publisher: UniversityOfHealthCare
Binding: Paperback
ISBN: 1594912602
Category: Programming
List Price: $ 59.95
Price: $ 699.90
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Part 11 and Computer Validation Guidebook
This is a package of Agent GXP FDA Part 11 and Pharmaceutical Computer Validation Introduction. Programming books Part 11 and Computer Validation Guidebook pdf. These two related titles 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. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough section 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. Download books 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry pdf via mediafire, 4shared, rapidshare.
Price comparison for 21 cfr part 11: complete guide to international computer validation compliance f
Price: $206.23
author orlando lopez format hardback language english publication year 15 01 2004 subject mathematics sciences subject 2 science general reference title 21 cfr part 11 complete guide to international computer validation compliance for the pharmaceutical industry author orlando lopez publisher informa healthcare publication date jan 01 2004 pages 264 binding hardcover edition 1 st dimensions 7 50 wx 9 75 hx 0 75 d isbn 084932243 x subject science chemistry analytic description this guide deline
author orlando lopez format hardback language english publication year 15 01 2004 subject mathematics sciences subject 2 science general reference title 21 cfr part 11 complete guide to international computer validation compliance for the pharmaceutical industry author orlando lopez publisher informa healthcare publication date jan 01 2004 pages 264 binding hardcover edition 1 st dimensions 7 50 wx 9 75 hx 0 75 d isbn 084932243 x subject science chemistry analytic description this guide deline
Price: $89.99
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
Price: $89.99
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
Price: $89.99
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
Price: $89.99
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
"Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance
Download Part 11 and Computer Validation Guidebook
These two related titles 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. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough section 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. 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. 224 pages in the manual include handy printouts of many relevant FDA regulations. For convenience, the CD contains the text of some of the regulations. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version. Download free Part 11 and Computer Validation Guidebook pdf
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