JVT

An Introduction to June’s Journal

Welcome!

If you are a new reading to the Journal of Validation Technology, thank you for stumbling upon our publication. For our longtime readers, thank you for your loyalty. As a group, we have surveyed readers and used your feedback to reach out to top experts to address top issues in the industry. A few of our features are written and co-written by our very own Editor-in-Chief, Paul Pluta, Ph.D. Pluta continues his series on Validation Master Plans (VMP), this time with a focus on site and function validation plans. Early review of the VMP sets the tone for the rest of an audit so this piece will get your facility off to a good start. Pluta also co-authors a paper with Alan Mancini on “Like for Like” Change Problems, showcasing real-life stories reflecting compliance problems in pharmaceutical, medical device, and related industries.

To continue the theme of laboratory readiness that so many have questions about, Alice Krumenaker presents “Laboratory Compliance and Inspection Readiness.” The paper addresses training, procedures, instruments and data systems, and electronic data – you won’t want to miss it.

In addition, we feature an introduction on Quality Risk Management, written by Amjad Ganma of Tabuk Pharmaceuticals located in Saudia Arabia. With so many moving parts in a laboratory or facility, maintaining an “acceptable” level of risk is of the utmost important to minimize threats.

Lastly, Aris Koumandaros of Sanofi Pasteur wrote an illuminating paper on “Building a Quality Culture that Supports Data Integrity in the Pharmaceutical Industry.” Like the rest of the papers this journal, this paper will assist a company maintain compliance and ultimately, protect public safety by ensuring product quality.

As always, we appreciate your feedback to make upcoming issues of JVT better than the last. If you have an idea for an upcoming paper, would like to write or be part of our Editorial Advisory Board, please email me at Melissa.carella@ivtnetwork.com.

In addition, to stay current with some of the best in-person industry training, take a peek at our events calendar

Sincerely,

Melissa Carella

Managing Editor, JVT & GXP Journals




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