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Understanding Closed-Loop CAPA System

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

Compliant CAPA assures the FDA of a proactive system with a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality.  The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for resolution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system.  Avoid a "shoot from the hip" approach.  Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system. Then document the results.

Course Objectives:

This webinar will discuss closed-loop CAPA, which mandates a repeatable, systematic data capture, Failure Investigation and Root Cause Analysis.  These are often discussed, but little understood disciplines among those who could benefit most from its use.  With reason, the most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance, is pro-active in finding and remediating problems / non-conformances without the Agency constantly auditing it.  However, one of the most cited 483 observation is failure to address / resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Impact-analysis and Trending are other oft-neglected CAPA required activities. Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Course Outline:

• CAPA – It’s three main components

• US FDA Expectations / QSIT

• Failure Investigation / Tools

• Root Cause Analysis / Tools 

• Impact Anaysisl

• “Gate Keepers”?

• Accurate and Complete Data Capture?

• Documentation

• Addressing extended CAPA resolutions

• “Closed Loop” and ‘Bullet-Proof”? 

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• R&D

• CAPA personnel

• Engineering

• Supervisors

• Business Owners

• General Managers

• Marketing

• Company owners

• Presidents and CEO's

• QA / RA

• Managers

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


Refund / Cancellation policy

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Subject : Understanding Closed-Loop CAPA System

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