Powerful Closed-loop CAPA - Meeting FDA Expectations

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Why Should You Attend:

The most important area audited by the FDA is CAPA - it assures the FDA that company is in compliance without the Agency constantly auditing it.

Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis - define, locate and resolve the basic problem(s) or root cause(s). 

Areas Covered in the Seminar:

• U.S. FDA's Expectations.
• Elements of a truly "closed loop" CAPA system.
• Accurate Description with A Sample Failure Investigation Template.
• 7 Powerful Tools for Root Cause Analysis.
• Investigation Detail - Root or Probable Cause.
• Impact -- Often neglected but of major importance.
• Correction, Corrective Action, Preventive Action.
• Effectiveness -- Determining and Monitoring.
• Institutionalize.

for Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702012?channel=ScienceDZ