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Achieving a Culture of Quality by Design

Achieving a Culture of Quality by Design – Quality Quarterly Issue 7

PDF Version In this spring issue of Quality Quarterly, I explore the idea that the philosophical underpinnings of a “Quality by Design” (QbD) framework for pharmaceutical product development can be applied to achieving a “Culture of…

Investigating Unforeseen Outcomes in a Culture of Quality

PDF Version 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…

Total Analytical Error (TAE) from Concept to Calculations

Do you struggle with understanding statistical concepts applicable to your role and responsibilities in the development of biologics? Are you aware of the trend toward Bayesian statistical inference and the shift away from the frequentist…
Nancy Sajjadi

Developments in Bioassays

For over 30 years, I have been involved in the quality control of experimental biologics and have witnessed both incredible outcomes and tragic disappointments in addressing many different unmet clinical needs. I recently attended a conference…

CHI podcast The Chain Interview June 2021

In this interview, Nancy describes her unconventional journey to becoming a scientist and how her early childhood experiences influenced her recent decision to expand the scope of her business.  She gives her insights into the quality challenges…