Complete understanding of RCA and CAPA

All the learning Areas:

o    Regulatory Expectations for Investigations

o    What is RCA and Typical Problems

o    Investigation Process Overview

o    Skills and Tools of an Effective Investigator

o    (Re) Introduction to Root Cause Analysis (RCA)

• Principles of root cause analysis
• Why root cause analysis is difficult
• Methodology of root cause analysis

STEP 1 - Problem Definition

• How to ensure that the right problem is being worked on
• Tools and filters for priority setting
• Developing a clear and sufficient problem statement (includes practice)

STEP 2 - Understanding the Process

• How every problem is a process failure
• How diagrams can set boundaries and define interrelationships
• Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 - Identifying Possible Causes

• Multiple ways to identify possible causes
• Options for selecting or eliminating causes
• Logic trees as a cause and effect diagram and other tools for investigations

o    Defining the Deviation

o    Identifying Root Cause

o    Corrective and Preventive Actions (CAPA)

• What is the CAPA System
• Definition and regulatory interpretation
• Identifying and writing of corrective actions
• Abuses of the CAPA system
• Discuss robustness and effectiveness review

o    Management of the Investigation

o    Members of the Investigation Team

o    Consulting Case Study Practice - Incident/Events

o    Case Study Practice

o    Interactive Exercises and Discussions.

Complete understanding of RCA and CAPA