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Investigating Unforeseen Outcomes in a Culture of Quality

A willingness to investigate unwelcome results is integral to building and maintaining a culture of quality. My first two Quality Quarterly issues focused on bioassays and total analytical error. I chose these topics because the resolving…

Interview with Kaitlyn Barago

In this short interview, Nancy reviews her education and experience in the development of cell and gene therapy products.  She provides insights into how the complexity of biologics make bioassay design, development, and validation of assays…

The Positive Value of Employee Attachment

In this interview by Cecile Alper-Leroux, VP of products and innovation at UKG Ultimate Software, a developer of human analytics, Nancy describes how the uniquely human capacity to develop deep bonds is the outcome of very complex brain biochemistry…

Helping Organizations Address Employee Absenteeism, Disengagement & Rising Health Care Costs

In this interview, Nancy describes the origins of her business called Life Quality by Design and its initial focus on employee well-being and organizational wellness programs. Since this 2018 interview, Nancy has merged her biotech consulting…

Assessing parallelism prior to Determining Relative Potency

With nearly 50 citations, this paper summarizes the unanimous agreement of a USP committee, that the method for assessing parallelism that is currently presented in 〈111〉 and in the European Pharmacopeia's Chapter 5.3 is flawed and should…

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