Part 11 and Computer Validation Guidebook

by Bruce Gordon

This is a package of Agent GXP FDA Part 11 and Pharmaceutical Computer Validation Introduction. These two related titles will give the learner an excellent introduction to computer issues in the pharmaceutical industry. 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. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough section 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. 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. 224 pages in the manual include handy printouts of many relevant FDA regulations. For convenience, the CD contains the text of some of the regulations. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.

323 pages, Paperback

First published August 1, 2005

About the author

Titus Street Professor of Ecclesiastical History

http://divinity.yale.edu/gordon
bruce.gordon@yale.edu
Denomination: Presbyterian

A native of Canada, Bruce Gordon taught from 1994 to 2008 at the University of St Andrews, Scotland, where he was professor of modern history and deputy director of the St Andrews Reformation Studies Institute. His research focuses on European religious cultures of the late-medieval and early modern periods, with a particular interest in the Reformation in German-speaking lands. He is the author of Calvin (Yale University Press, 2009), a biography that seeks to put the life of the influential reformer in the context of the sixteenth-century world. It is a study of Calvin’s character, his extensive network of personal contacts and of the complexities of church reform and theological exchange in the Reformation. The Swiss Reformation (Manchester University Press, 2002) (an “Outstanding Publication” for 2003 by Choice Magazine) studies the emergence of the Reformation n the multi-lingual world of the Swiss Confederation and its influence across Europe in the sixteenth century. His book Clerical Reformation and the Rural Reformation (1992) examined the creation of the first Protestant ministry, which took place in the Swiss city of Zurich and its numerous country parishes. In addition, he has edited books on the development of Protestant historical writing, the relationships between the dead and the living in late-medieval and early modern society, the Swiss reformer Heinrich Bullinger, and, most recently, on biblical culture in the sixteenth century. He was the principal investigator of a major grant from the Arts and Humanities Research Council of the United Kingdom on Protestant Latin Bibles of the Sixteenth Century. The project explores the new translations of the Old and New Testaments by Protestant scholars into Latin during the Reformation and the questions posed by these extraordinary works for our understanding of translation, authority, material culture, confessional identity and theological formulation. The monograph is currently being completed. He has started work for Princeton University Press on a study of the reception of Calvin’s Institutes from the Reformation to the modern world. His teaching includes a lecture course on Western Christianity from the early church to the scientific revolution, and seminars on the culture of death, sources and methods of religious history, the Reformation, Calvinism, and the Reformed tradition from Zwingli to postmodernism. He teaches in the Department of History and in Renaissance Studies and works with graduate students on a wide range of topics in early modern religious history. He is on the board of various publishing series: St Andrews Studies in Reformation History (Ashgate), Zürcher Beiträge zur Reformationsgeschichte (Theologischer Verlag Zürich), and Refo500 Academic Studies (Vandenhoeck &Ruprecht). He is a fellow of the Royal Historical Society and in 2012 received an honorary doctorate from the University of Zurich, Switzerland. (Presbyterian)

Read a feature article about Professor Gordon.




Education

B.A. (Hons) King’s College
M.A. Dalhousie University
Ph.D University of St. Andrews


Books



1. Shaping the Bible in the Reformation. Books, Scholars and Their Readers in the Sixteenth Century, ed with Matthew McLean (Brill, 2012).

2. Calvin. 1509‐1564 (Yale University Press, 2009)

3. Architect of Reformation. An Introduction to Heinrich Bullinger, 1504‐1575,
co-ed. (Baker Academic, 2004)

4. Translation and Edition of Hans R. Guggisberg, Sebastian Castellio. Defender
of Religious Toleration (Ashgate Press, 2003)

5. The Swiss Reformation (Manchester University Press, 2002)

6. The Place of the Dead in Late Mediaeval and Early Modern Europe, ed. with Peter Marshall (Cambridge University Press, 2000)

7. Protestant History and Identity in Sixteenth‐Century Europe, 2 vols., ed.
(Scolar Press,