James P. Catania is a managing consultant at Tunnell Consulting
Quality by Design: The Case for Change (Part II)
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
Quality by Design: The Case for Change
Executive management leadership is essential in the effective implementation of QbD.
How to Reduce Unnecessary Compliance Costs
By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.