Pharmaceutical Computer Validation Introduction 5 Users: GMP (Good Manufacturing Practices) Training Introduction to Meet FDA Regulations in the Use ... on Computer System Validation and Part 11

This title is part of the UniversityOfHealthCare/ UniversityOfBusiness Interactive Training Library, which offers authoritative, clearly written material in an interactive form for better comprehension and documentation of completion. 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. For convenience, the CD contains the text of some of the regulations. 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. You will need Internet access to e-mail us your unique key and receive a password key. The multiuser CDs are designed for organizations that wish to train and test a number of people at a discounted price and retain the information in the course for future reference. Each user who passes successfully with a score of 80 may print a certificate of completion. Each CD may only be activated on one computer and contains tests for up to the number specificed in the title.