The Journal of GXP Compliance
Vol. 25, Issue 4, Jul 2021

Orlando Lopez
Once a vast quantity of data is being generated and stored, it is becoming important to preserve the integrity of the information that’s collected. Understanding the basics of data integrity (DI) and how it works is the initial step in retaining the reliability of the data and keeping it safe. This article provides the DI issues in a Data...
Kurt L. Moyer
,
Richard C. Wedlich
Laboratory records play a large part in incident and accident investigation. In this, fourth and final manuscript, of the Laboratory Safety series, the authors provide details on creating standardized written SOPs for routine lab operations and plan for ensuring safety at the bench.
Paul L. Pluta
This paper continues a series of discussions addressing the application of validation principles to the Training Quality System (TQS). The activities of training management supportive to actual employee training are discussed. These activities are part of a proposed structured approach to training management based on the lifecycle approach to...
Jeanne Moldenhauer
In this article the author reviews previous FDA 483 observations and provides insight in preparing for audits and regulatory inspections. Throughout we see ways to avoid warnings through analysis and formatting of data, as the largest number of observations revolve around failed documentation and faulty written procedures.
Karen R. Zimm
,
Renee Phillips
Establishing and maintaining compliance through solidly built quality systems and adherence to the current Good Manufacturing Practices are the foundational pieces to success in regulated industries of pharmaceuticals, medical device and biotech. In this article we will hear of failures leading to recall, and how to avoid this by reducing the...
Tim Sandle
Women make up the majority of the workforce in pharmaceuticals and healthcare globally, yet the distribution of pay, other benefits, scientific standing, representation in leadership positions, and access to certain occupations, is highly disproportionate. Some progress is being made, especially with more women occupying higher positions within...
David Harris
Senior Leadership has to make hard decisions about investments. We see headlines about mergers, acquisitions, partnerships, opting in on products that have exciting development or preclinical results. The headlines may also include significant investment in internal infrastructure. Hundreds of millions of dollars may be directed to building a new...
Tim Sandle
Respiratory droplets are coronaviruses primary transmission mode and thus the majority of coronavirus risk mitigation strategies focus on the control of air. However, surface contact remains an alternative infection route. Hence, it remains a concern that the SARS CoV-2 virus can remain viable on surfaces for several hours.
Kaiser Jay Aziz
The timelines for the various studies and their integration into a formal therapeutic drug development plan are compound specific and dependent on the availability of resources within the various departments of the sponsor firm and approval of sponsors management. At the same time, the designation of pertinent milestone events and the critical...
Welcome to another episode of Voices in Validation brought to you by the IVT Network. We are proud to be your source for industry news, networking and education. As part of our continued effort to give back to the industry, and our valued audience, we are share this insightful session from our recent conference. We invite you to listen in this...
This time we invite Valarie King-Bailey to share her thoughts on this discussion, focusing in on some key clips and information. Listen in as we take a deeper dive into the topic and provide a consultant's view of the current state of Quality Systems and the future monitoring.
In this episode our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life? How can we build a culture that embraces risk management? All of that and more in this...
In this episode of Voices in Validation we are joined by Robin Toft to speak about the challenges of attracting and hiring top talent, tactics for building and retaining a workforce, and the technologies that are changing the ways we recruit, hire and train our teams.
In this episode we share the Digital Transformation panel discussion from the CSV conference this past spring. The panel of experts bring insights into organization-wide digital transformation initiatives, first-hand experiences of point solutions, and platform transitions, as well as lessons learned in cloud computing and cloud first approaches...
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