The Journal of GXP Compliance
Vol. 23 , Issue 5, Sep 2019

Tim Sandle
This article examines some of the reasons for this variation in relation to the test and the test reagents. The article also examines the coefficient of variation which is one way to examine for test variation. Coefficient of variation is measure of precision; the precision of an analytical procedure is the degree of agreement among individual...
Lorianne Richter; Anne Greene
In this first article, we consider whether our CGMP learning programs providing the benefits that we are seeking; with effective knowledge transfer relevant to the adult learner in the CGMP environment. In the second and third article in this series, we will explore these questions, with actual examples to determine if the needs of the adult...
Jeanne Moldenhauer
It is often noted that some of the biggest scientific advancements frequently arise from laboratory mistakes or errors. This article discusses the finding from a laboratory incident which yielded a genetic circuit resulting in stem cell-like bacterial differentiation.
Karen R. Zimm
Welcome to regulatory 101. This is the launch of a new forum forum for pharma professions to share information about how they manage their respective quality and compliance responsibilities with regulatory considerations. This first release highlights common question in improper storage conditions, often referred to as environmental excursions.
Paul L. Pluta
This discussion continues a multipart series of discussions in which principles utilized in validation are proposed for application to the training quality system.The structure and order of the lifecycle approach is directly applicable to trainees. A comprehensive life cycle approach including Stage 1 trainee prerequisites before initiation of...
Paul L. Pluta
For professionals in the pharmaceutical and medical device industries who must write or revise documents to GMP compliance standards know how time consuming and tedious it can be. This article serves as guidance for the do's and don'ts of technical writing for compliance, as well as a checklist of must haves to avoid citations.
Martin Lipa, Paige Kane and Anne Greene
While knowledge management (KM) has been widely applied in other sectors, the international biopharmaceutical sector has struggled with the meaningful and sustained application of effective KM practices. This is evident even though KM has been highlighted in regulatory guidance for over 10 years, and the positive business impact of KM is well...
Willis H. Thomas
This article is derived from a live presentation on the same topic. This article will highlight the important takeaways, and top items of interest in describing the Human Error Reduction and prevention in validation and compliance activities. The discussion includes an overview of common questions including: What factors cause human error in...
Stacey L. Bruzzese
Whether you work in pharmaceutical manufacturing, computer science, or the laboratory, if validation and compliance are important to you don't want to miss this event! IVT Network, the foremost source for life sciences validation and compliance knowledge, presents its flagship event, the 25th Annual Validation Week October 16-18, 2019 in Las...
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