ABSTRACT

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co

chapter 1|20 pages

In the Beginning There was GLP

chapter 2|38 pages

Before GCP

chapter 3|16 pages

Training in the Regulated Environment

chapter 4|28 pages

Computing in the Regulated Environment

chapter 5|26 pages

QA Activity

chapter 6|20 pages

Beyond Compliance

chapter 7|30 pages

Business Improvement

chapter 8|28 pages

A Summary