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  • CAPA, Failure Investigation and Root Cause Analysis - FDA
    Expectations

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Mar 25, 2014 10:00 AM
  • End Time:
  • Tuesday - Mar 25, 2014 11:30 AM
  • Location:
  • Online
  • 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). 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.
    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.

    Areas Covered in the Webinar:
    -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


    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


    Instructor Profile:
    John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company. He has over 32 years experience in U.S. FDA-regulated industries, 18 years of which have been as a full time, practicing consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, and conducted workshops and webinars worldwide. He is a graduate of UCLA.
  • Website:
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