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Powerful Closed-loop CAPA - Meeting FDA Expectations

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

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.

Course Objectives:

The most important area audited by the FDA is CAPA - it assures the FDA that companies are 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). A full-capture investigation, verification/validation, monitoring, change control methodology, coupled with accurate root cause analysis is crucial to a closed-loop CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations.

Why Should You Attend:

This webinar will present simple but powerful tools, the systematic and regular use of which, can resolve the key underlying problem and close out CAPA documents in a timely manner. The information and tools presented in this webinar can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Course Outline:

• U.S. FDA's CAPA Expectations

• What is Closed-loop CAPA?

• Correction, Corrective Action, Preventive Action

• Failure Investigation Using an FI Template

• 7 Powerful Tools for Root Cause Analysis

• Investigation Detail - Root or Probable Cause

• Impact - Often Neglected but of Major Importance

• Effectiveness - Determining and Monitoring

• Institutionalize vs. Entropy

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology / defined systems, and simple but powerful tools for closed-loop CAPA, including proper failure investigation / root cause analysis and making the fix permanent. This applies to companies in the medical device, diagnostic, pharmaceutical, and biologics fields. The employees who will benefit include:

• Senior management

• Regulatory affairs

• Quality assurance

• Production

• R&D and engineering

• All personnel tasked with problem solving

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

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Subject : Powerful Closed-loop CAPA - Meeting FDA Expectations

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