Foreword Reviews Gives UniversityOfHealthCare GMP Training Package a Five-Star Book/CD Review Rating; Collection of Titles is Useful for Pharmaceutical, Medical Device, Cosmetics, and Food Industries

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Foreword Reviews gave the UniversityOfHealthCare GMP Training Package a five-star book/CD review rating. This is a collection of titles useful for the pharmaceutical, medical device, cosmetics, and food industries.

Foreword Reviews gave the UniversityOfHealthCare GMP Training Package a five-star book/CD review rating.

This title is a package of three titles, also available for separate purchase:

  • Agent GXP FDA Part 11
  • Pharmaceutical Computer Validation Introduction
  • Pharmaceutical Quality Control Lab

This program is available in the following formats:

  • Web-based on the UniversityOfHealthCare website at http://www.uohc.com/courseentry.htm
  • CD-ROM, Manual/CD-ROM combination, or Library Edition Manual/CD combination at http://www.atlasbooks.com/uohc (Libraries and bookstores may also obtain through Ingram and Baker and Taylor, but Atlas Books has the most recent titles and will handle back orders.) Also available at http://www.uohc.com.
  • Group licensing for a corporate Learning Management System
  • Multiuser site licenses are already available and more will be available shortly for some of the parts of the package. Contact the company for more information or http://www.uohc.com/MultiuserCDSales.htm

This package covers some of the most important areas of modern pharmaceutical regulations and manufacturing. It will also be valuable for anyone involved in clinical trials: CROs, pharmaceutical companies, individual doctors, and hospitals.

“Part 11” refers to the FDA regulations on electronic records. These regulations impact everyone in FDA-related industries.

All the titles in the package enable the documentation of successful completion with a certificate, and provide an excellent method to document training for an FDA audit.

The unabridged review is reprinted below.

UniversityOfHealthCare is a total e-learning solutions provider for management and healthcare. Its services include implementation of a learning management system, consulting, hundreds of web-based courses, and manual and CD publishing. For example, it has unique series on Bioterrorism, JCAHO and OSHA compliance, HIPAA training, Leadership, Pharmaceuticals, and much more.

The UniversityOfHealthCare website is http://www.uohc.com and the CD catalog is at http://www.uohc.com/CDROMs.htm. That page has a link to slide shows of screen shots from the courses.

The Review

This comprehensive training tool includes a CD and book which work in tandem to give readers three courses on updated pharmaceutical rules and regulations. Effective August 20, 1997, the Food and Drug Administration issued regulations known in the industry as "Part 11" which require specific record-keeping and security measures, but which have been frequently misinterpreted. Especially by those who most need to master them.

Detailed information on these FDA regulations for pharmaceutical manufacturing including clearly stated segments on computer validation, security measures, and pharmaceutical lab quality control are included, making this package of great value to just about anyone who works with prescription drugs.

Some of the more general material is also applicable to those in other FDA-regulated areas such as cosmetics and processed food manufacturing.

Authors Daniel Farb, MD and Bruce Gordon use humor and a narrative involving a hostage rescue by Agent GXP. The spoof makes fun of the complexities of Part 11, a storyline most can relate to, and in the process delivers important information about the regulations. The authors have made a dry, but crucial subject, entertaining and interesting to learn about and master.

A glossary deftly defines related terminology such as "Audit Trail," "Legacy System," and "Transaction Safeguards." The CD is the main component of the tool, however, and graphics, sound, and the acting of the characters in the hostage scene are exemplary.

The two other sections of the book and CD are Pharmaceutical Computer Validation Introduction and Pharmaceutical Quality Control Lab course, the latter of which two additional authors, Robert Kirsch, PhD. and Anthony Luttrell, contributed to. Each of these sections, while less entertaining than the story of Agent GXP, provide the necessary "nuts and bolts" of facts and procedures crucial to gaining complete compliance with record-keeping and safety regulations. The three work seamlessly together.

As with other publications from the interactive library of University of Healthcare/University of business, readers have the opportunity at the end of the CD to take a test to help gauge what they have retained. Those who pass receive a certificate of completion. The results of this test can be used to increase their confidence in their own abilities and knowledge, to prepare for a job change, or by employers to improve their workforce.

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Judy Terracina