Moving beyond human error In biopharma investigations and CAPA programs (16 November 2020)

Summary

A conversation with John Wilkes (AstraZeneca), Clifford Berry (Takeda), Amy D. Wilson, Ph.D. (Biogen), and Jim Morris (NSF Health Sciences).

This article is the second part of a two-part roundtable Q&A on the topic of human performance in pharmaceutical operations. Part 1 evaluated the underpinnings of human performance and provided advice to those individuals managing rapid production scale-up to support COVID-19 production demand. Here in Part 2, human performance in the context of investigation and CAPA programmes is considered.