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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…

Quality Quarterly Issue 6 – Innovation in the Biologics Space

PDF Version New Open Access Paper to Share! Happy Q1 2024! Have you taken time to identify what led to the greatest growth and learning for you and your team last year? I think doing so provides not only a healthy reminder of all the accomplishments…

The Importance of Reference Standard Management Programs in Drug Development

PDF Version For those who liked (or missed) my attempt at a beach read, you can download QQ#4 on significant figures in PDF format. Not everyone enjoys nor needs to get into the nitty gritty of calculations, but some appreciated being walked…

Practical Considerations in Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose

BioProcessing Journal  has published a second manuscript by Dr. Janice Callahan and I as a follow-on to a prior publication proposing an equivalence model for lot release and vector dose assignment. This latest publication outlines the scope…
Significant Figures, Quality Quarterky 4

Significant Figures

PDF Version If this issue goes out according to schedule, it will be precisely 0.8876712328767120 years since I launched the Quality Quarterly. I want to mark this ~1 year anniversary by thanking those who have taken time to reply to the…