Item description for GMP Training Package by Daniel Farb...
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. This is a package of three related products that cover the most important areas of modern pharmaceutical GMP regulation. (1) Agent GXP Part 11, used by thousands in the pharmaceutical industry, teaches the regulations of Part 11 on electronic records through a spoof of a hostage story. 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. (2) In the related field of computer validation, an overworked manager makes a deal with the devil to prepare for an FDA inspection. This course gives you a comprehensive introduction to computer systems validation as the computers come to life. 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 of each course, you will receive a certificate of completion to document your training for the FDA or for employers. Estimated time: 2-3 hours. (3) The course on the 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. 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.
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Est. Packaging Dimensions: Length: 5.6" Width: 4.9" Height: 0.4" Weight: 0.1 lbs.
Release Date Aug 20, 2003
ISBN 1932634584 ISBN13 9781932634587