The Journal of Validation Technology
Vol. 25, Issue 5, Oct 2019

Stacey L. Bruzzese
The 2019 Val Week event held in Las Vegas was a very special event celebrating 25 years of the conference and featured some speakers, like Gamal Amer and Paul Pluta, who have a long history with CBI and the IVT Network. This year's event had plenty of new offerings as well, including a mock inspection, grateful leadership series and tracks...
Paul L. Pluta and Alan M. Mancini
CQV – Compliance in Quality and Validation – presents real-life stories reflecting compliance problems in the pharmaceutical, medical device, and related industries. Previous discussions have included:
Tim Sandle
This article reviews good hygiene design for pharmaceutical facilities. Covering a wide range of data, specific examples selected are intended to be illustrative. Six subject areas are reviewed, Hygienic design - what is it, Materials of choice, Equipment selection; valves, pumps, vessels, Pipework and system design, Processing conditions and...
Orlando Lopez
What can go wrong during the validation process? From the context of Big Data functionality, the infrastructure, repository mappings, and integration sequencing are critical elements to consider during the functionality design process. This article discusses a variety of points for consideration and some action steps for validation of Big Data.
Ivan Soto
Selecting a cleaning agent is one of the many critical steps that need to be define during cycle development. Selecting the right cleaning agent requires a science-based approach that begins with understanding all of the potential sources of contributing residues, equipment design issues and process issues, as well as limitations of cleaning...
Paul L. Pluta
The latest PQ Forum addresses the use of numbers in validation and other technical documents. The writing of numbers in these documents may violate technical writing norms, be inconsistently presented within the document, and have grammatical errors. Numbers in technical documents differ from numbers in non-technical applications; technical...
Jeanne Moldenhauer
This article provides case study materials for the purpose of demonstrating FDA findings specifically identifying issues in aseptic processing.
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...
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