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Validity : 15th Apr'24 to 25th Apr'24
Root Cause Analysis and Tools
- Regulatory Issues
- Failure Investigation using an FI Template
- 7 Easy / Powerful Root Cause Analysis Tools
- Data Sources / Metrics
- Impact -- Often neglected but of major importance
- Effectiveness -- Determining and Monitoring
Overview of the webinar
A repeatable, systematic Failure Investigation and Root Cause Analysis, is at the heart of many major CGMP-mandated activities: CAPA, Verification and Validation, Non-conformances, Out of Specification conditions, and basic Failure Investigation. It is at the heart of a closed-loop, bullet-proof CAPA system. These are part of the top four areas targeted/audited by the FDA. CAPA / FI / RCA assures the FDA that a company will be in compliance without the Agency constantly auditing it. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents – Complaints, NCMRs, OOS’, Audit findings, et al, in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s), rather than just the symptoms. Regular, defined, systematic use and documentation of a few simple but powerful tools and their results will contribute greatly to the reduction of product liability, cost reduction efforts, less chance of recalls, better CGMP compliance and an improved bottom line.
Who should attend?
- Senior Management
- Middle Management
- QA/RA
- CGMP Compliance Auditors
- Consultants
- Six Sigma Leaders
- Operations
- Production
- Engineering
- Marketing
Why should you attend?
A full problem capture, investigation using root cause analysis tools, verification/validation, active monitoring and change control methodology, is crucial to meet the U.S. FDA's expectations of a true "closed-loop" CAPA system. It is at the heart of many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, Verification and Validation activities, Audit corrective and preventive actions, related Failure Investigations, et al. Simple workflow definition and root cause analysis tools are not understood, disseminated, and used consistently. Product failures, liability issues, scrap / waste / fall off and needless recalls result, as evidenced in recent news reports. 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. Define and resolve root problems/causes not just symptoms. And also benefit your company's bottom line.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John 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 software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. 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 ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.