Powerful Closed-loop CAPA - Meeting FDA Expectations

Why Should You Attend:

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.

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

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to 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 so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.

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