Pharmaceutical Computer Validation Introduction: Gmp (Good Manufacturing Practices) Training Introduction to Meet Fda Regulations in the Use of ... Device, Food, and Cosmetics Manufacturing) - Softcover

Farb, Daniel, M.D.; Gordon, Bruce

Softcover

ISBN 10: 1594910367 ISBN 13: 9781594910364

Verlag: UniversityOfHealthCare, 2004

Inhaltsangabe

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.

Details zur Ausgabe

• Verlag: UniversityOfHealthCare
• Erscheinungsdatum: 2004
• Sprache: Englisch
• ISBN 10: 1594910367
• ISBN 13: 9781594910364
• Einband: Taschenbuch
• Anzahl der Seiten: 86
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Nicht verfügbar