With Emphasis on Computer System Validation and Part 11 (Pharmaceutical Computer Validation Introduction: GMP (Good Manufacturing Practices) Training ... Device, Food, and Cosmetics Manufacturing) - Softcover

Farb, Daniel; Gordon, Professor Bruce

Softcover

ISBN 10: 1594910367 ISBN 13: 9781594910364

Publisher: UniversityOfHealthCare, 2004

Synopsis

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. 153 pages on CD. 86 pages in the manual include a handy printout of several relevant FDA documents. For convenience, the CD contains the text of some of the 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.

About this title

Synopsis

This title contains a book & a CD-ROM. "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 of this title is: 2-3 hours. There are 153 pages on CD and 86 pages in the manual that include a handy printout of several relevant FDA documents. For convenience, the CD contains the text of some of the 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.

Edition details

• Publisher: UniversityOfHealthCare
• Publication date: 2004
• Language: English
• ISBN 10: 1594910367
• ISBN 13: 9781594910364
• Binding: Paperback
• Number of pages: 86