Applying GMP Quality Principles to Deviations & Nonconformities and Effective Corrective And Preventive Action Systems

13 September 2011, Houston, United States

Introduction

Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the "Why" and the "How". Although quite informal, this is a rudimentary CAPA system.