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Author: Daniel Farb
Publisher: University of Health Care
ISBN: 9781594910258
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Daniel Farb
Publisher: University of Health Care
ISBN: 9781594910258
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Daniel Farb, M. D.
Publisher: Universityofhealthcare
ISBN: 9781594910951
Category : Business & Economics
Languages : en
Pages : 224
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Book Description
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.
Author: Daniel Farb
Publisher: UniversityOfHealthCare
ISBN: 1594912602
Category : Computer security
Languages : en
Pages : 329
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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: Daniel Farb
Publisher: Universityofhealthcare
ISBN: 9781932634679
Category : Medical
Languages : en
Pages : 86
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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, and so on.
Author: Robert McDowall
Publisher: Royal Society of Chemistry
ISBN: 1847552293
Category : Science
Languages : en
Pages : 289
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Book Description
Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848297
Category : Computers
Languages : en
Pages : 298
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Book Description
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.
Author: Robert D. McDowall
Publisher: Royal Society of Chemistry
ISBN: 1849736626
Category : Science
Languages : en
Pages : 778
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Book Description
Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
Author: Daniel Farb, M.D.
Publisher: Universityofhealthcare
ISBN: 9781594910265
Category : Business & Economics
Languages : en
Pages : 258
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Book Description
Author:
Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
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Book Description
Author: Orlando Lopez
Publisher: CRC Press
ISBN: 1315349973
Category : Business & Economics
Languages : en
Pages : 268
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Book Description
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.
