CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Topics

• The Basic Steps to Problem Solving
• Regulatory "Hot Buttons"
• ID / Document the Problem -- CAPA, et al
• A Suggested Investigation Template
• Use the 7 Tools to Find the Solution(s)
• Failure Investigation / Analysis Methodology -- And One Possible Template
• Lock In the Change - Close the Loop
• Monitor for Effectiveness
• Take It to the Next Level

Who should Attend

QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities and Operations.