Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy
May 2 - 4, 2012 - King of Prussia PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
This three-day course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA. The course provides clarification of regulatory expectations and guidance, and the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will practice root cause analysis techniques and identify corrective and/or preventive actions towards successful remediation and closeout. Attendees will gain a perspective of effective interviewing and writing skills, discuss common pitfalls, and develop tips and techniques for thorough investigations and elimination of recurring failures and deviations. Additionally, attendees will learn through hands-on activities such as group discussions and case studies tailored to regulated industries.