About this document

CAPA Management for Pharma Productivity by Darren Tan is a document available to read on EtoBox.

- CAPA (Corrective and Preventive Action) is a major focus of FDA inspections and the leading cause of FDA observations, with around 40% of FDA 483s relating to CAPA issues. - While companies see CAPA as a compliance need, the author argues it should be viewed more broadly as a tool to improve productivity. Effective CAPA management can help reduce rework and improve quality and productivity. - The author proposes a new approach where CAPA is integrated into core operations, part of corporate risk manageme

Author

Darren Tan

Language

EN