This paper presents a practical way in which current approaches to quality risk management
(QRM) may be improved, such that they better support qualification, validation programs, …

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical,
medical devices and medical diagnostics industries. In particular, it explores the role …

Knowledge management (KM) is identified in ICH Q10 (Pharmaceutical Quality System), as
a key enabler to the pharmaceutical quality system (PQS). ICH Q8 (Pharmaceutical …

This report presents the findings from three years of Quality Metrics Research and builds on
seminal outcomes from earlier operations and quality management research, eg Voss et al.(…

This article is the first in a series of articles that will focus on understanding the
implementation essentials necessary to deliver operational excellence through a International …

The FDA Quality Metrics initiative has emerged directly from the FDA Science and Innovation
Act (US Congress, 2012)(FDASIA, 2012) and aims to provide both industry and regulators …

This chapter focuses on understanding the implementation essentials necessary to deliver
an 'effective quality management system for the pharmaceutical industry' and the crucial role …

This report, building upon the findings of the first year of the research project provides an
account of the research activities undertaken in the second year and presents an outlook for …

… The recent regulatory, industry and even media focus on developing the rightculture of
quality runs the risk of denigrating the idea of culture change to little more than a slogan (Calnan …

This conference paper presents an overview of the recently published FDA Process Validation
Guideline for the development and manufacture of medicinal drug products. It discusses …