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ComplianceOnline, Online Event
2012-08-07
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. Areas Covered in the Seminar: - U.S. FDA's Expectations.
- Elements of a truly "closed loop" CAPA system.
- Accurate Description with A Sample Failure Investigation Template.
- 7 Powerful Tools for Root Cause Analysis.
- Investigation Detail - Root or Probable Cause.
- Impact -- Often neglected but of major importance.
- Correction, Corrective Action, Preventive Action.
- Effectiveness -- Determining and Monitoring.
- Institutionalize.
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Organized by:
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Complianceonline |
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Invited Speakers:
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John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company. He has over 30years experience in U.S. FDA-regulated industries, 16 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.
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Deadline for Abstracts:
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2012-08-06
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Registration:
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For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702012?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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