Book DescriptionThis 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. Themanual accompanying the CD provides a summary of the major points of the CD in a handy format and includes copies of regulations. The GMP Training Package includes Agent GXP FDA Part 11, Pharmaceutical Computer Validation Introduction, and PharmaceuticalQuality Control Lab. These three courses will give the learner an excellent introduction to the most important areas of modern pharmaceutical manufacturing. 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 implementationof 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 systemsat 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. Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with out of standard and out of trend results in a pharmaceutical quality control lab. It contains an interactive flow chart, numerous step by step instructions, questions, an SOP model, and a case study. It is suitable for GMP training. Upon the successful completion of the course, you will receive a certificate of completion to document your training. Estimated time: 2-5 hours. All courses are 601 pages on CD. 258 pages in the manual include handy printouts of many relevant FDA regulations.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. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher. Это и многое другое вы найдете в книге GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, (Daniel, M.D. Farb)