PTI - international

Course Description

Failure to establish and maintain procedures for Root Cause Analysis (RCA) or Corrective and Preventive Action (CAPA) is a common deficiency cited in FDA 483s and Warning Letters. This comprehensive training course is designed to bring Pharmaceutical, Biotechnology and Medical Device manufacturers the most current knowledge about RCA and CAPA programs. The course covers the basics of CAPA and strategies to implement and maintain a CAPA system. It also examines the process of root cause analysis including the application of systematic methods for identifying root causes and contributing factors. Instruction on novel tools for gathering and analyzing RCA data and for implementing and validating your closed loop CAPA program is provided. After attending this highly interactive course, you will have the skills necessary to collect the facts, analyze data, pinpoint the problem and recommend solutions to eliminate future occurrences.