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Search - GMP Training Package Library Edition: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing

GMP Training Package Library Edition The FDA Regulations on Part 11 Electronic Records and Electronic Signatures for Pharmaceutical Medical Device Food and Cosmetics Manufacturing
Author: Daniel, M. D. Farb, Bruce Gordon, Anthony Luttrell, Robert, Ph.D. Kirsch

The GMP Training Package includes Agent GXP FDA Part 11, Pharmaceutical Computer Validation Introduction, and Pharmaceutical Quality 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 s... more »ignatures 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. 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. 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. 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.

ISBN-13: 9781594910968
ISBN-10: 1594910960
Publication Date: 1/1/2004
Pages: 258
Rating:

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Publisher: University of Health Care
Book Type: Paperback
Members Wishing: 0
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Search - GMP Training Package Library Edition: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing

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