The Journal of Validation Technology
Vol. 27, Issue 5, Oct 2021

IVT Staff
The team at IVT Network, together with our Esteemed Advisory Board, are proud to announce the recipients of the 2021 IVT Awards. These annual awards recognize the outstanding authors, speakers, podcast guests and presenters, who keep our audience informed and forward thinking.
Paul L. Pluta
“PQ Forum” provides a mechanism for validation practitioners to share information related to Stage 2 Process Qualification in the validation lifecycle. Information about supporting activities such as design and development, equipment, and analytical validation will also be shared. The information provided should be helpful and practical so as to...
Tim Sandle
In this article the author provides an overview of the characteristics of microbial attachment and the essential considerations when developing a contamination control strategy. This review paper assesses the factors affecting finish and roughness, primarily in relation to microbial attachment to stainless steel, while considering other related...
Paul L. Pluta
Discussion of non-technical management topics is always an area of interest in validation and QA professional meetings. Validation and QA functions are vital functions at a regulated manufacturing site. Validation and QA management must continually work to create a positive work environment in their respective functions. Mutual respect between...
Paul L. Pluta
,
Stacey L. Bruzzese
Critical Cleaning Forum (CCF) is a new IVT feature that will provide readers an opportunity to discuss information about cleaning and related topics. Critical cleaning -- cleaning to an appropriate quantitative level of cleanliness -- is a fundamental expectation in regulated industries. Cleaning is a process with a final “product” delivered by...
IVT Staff
The Risk Revolution series, part of the Voices in Validation podcast, uncovers the latest challenges in risk management, with the goal of advancing the maturity of risk management practices within the industry by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and...
IVT Staff
The U.S. Food and Drug Administration, FDA, released new guidance for industry this past week. Both impact Medical Device Manufacturers and offer further direction in identification and reporting requirements.
Tim Sandle
Many organizations within the pharmaceutical and healthcare space will be developing projects within the quality space. This requires the construction and maintenance of a ‘Quality Plan’. But what is the function and purpose of such a document? In this IVT article, the purpose and objectives of the Quality Plan are outlined.
Tim Sandle
In this article, the quality-based requirements for projects that appear within a Quality Plan are considered in terms of their application to quality management systems. This means considering project quality management, a function that encompasses the processes and activities that are used to figure out and achieve the quality of the...
Tim Sandle
When a project with a quality focus is devised it should connect to a Quality Plan and to the quality management system. The optimal way to ensure this connection is effective is to have defined structure. This article looks at the structure of a quality-based project by providing an anatomical breakdown of the core elements. Well-designed...
Siegfried Schmitt
This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other...
Chris Wubbolt
On this episode we invite you to count down the top five data integrity issues when complying with GXP guidance. Data Integrity is a critical element to GXP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and and ensure proper storage....
Nuala Calnan
,
Valerie Mulholland
This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more.
Bryan Prince
Implementation of the 2019 final version of USP 800 is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 standards. In this episode we discuss the impacts regulatory changes may...
Validated Cloud logo