Publisher's Synopsis
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 two related products: (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. (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.
