Root Cause Analysis - The Heart of a Successful CAPA Program 2016

Topics

• The 4 Basic Steps to Problem Solving
• Regulatory "Hot Buttons"
• ID/Document the Problem
• A Suggested Investigation Template
• Find the Solution(s)
• Investigation/Analysis Methodology - The 7 RCA "Tools"
• Lock In the Change - Close the Loop
• Monitor for Effectiveness
• Take It to the Next Level

Who should Attend

• QA Professionals
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• R&D Professionals
• RA Professionals
• Production Personnel
• Engineering Personnel
• Consultants
• Operations Personnel
• Others tasked with Product, Process, CAPA Resolution, Failure Investigation Responsibilities