The Journal of Validation Technology
Vol. 25, Issue 4, Aug 2019

Stacey L. Bruzzese
Check Out IVT's NEW Blog Series - We invite you to read the first posts in the series which highlight some of the most watched technologies and processes that our industry professionals are keeping abreast of. In our first posts, Dr. Tim Sandle advises us on the latest trends to impact our industry. Understand how artificial intelligence,...
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...
Karen R. Zimm
This article is intended for utilization as a reference for those considering opportunities for formalized educational pathways to regulatory affairs and quality assurance degrees. There are many different schools and programs that can be tailored to meet one’s educational needs. Programs vary from traditional in-classroom courses to online...
Tim Sandle
Unidirectional airflow devices and microbiological safety cabinets are a common feature in many laboratories, including applications to achieve contamination control. Such devices are suitable for a variety of applications and especially where a demarcated clean air environment is required for processing smaller items and for practicing aseptic...
Paul L. Pluta
Compliance in Quality and Validation (CQV #7) addresses compliance problems in the manual cleaning of pharmaceutical manufacturing equipment as identified by validation and quality managers, through the use of industry case studies and CAPA reviews.
Paul L. Pluta
This discussion addresses problems with usage of varied validation terminology within a pharmaceutical manufacturing site. Inconsistent use of validation terminology is an ongoing problem for validation managers. The development of a Validation Lexicon to standardize validation terminology and provide other benefits to the validation quality...
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