Why Should You Attend:
A repeatable, systematic Failure Investigation and Root Cause Analysis is the key to a continuously improving, proactive CGMP system . 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. Consequently, 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. However, one of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). FI and RCA also play a major part in successful verifications and validations and other CGMP activities. Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
Accurate and thorough Failure Investigation and Root Cause Analysis is a key to successful CAPA, validations and similar programs. It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, disseminated, and used, consistently. Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools will be presented and discussed as simple and effective means to accomplish FI/RCA. A breakdown in FI/RCA results in the product failures, liability issues, scrap / waste / fall off, and needless recalls, which we see listed on the FDA's website daily. Avoid a "shoot from the hip" approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of a "closed-loop" CAPA system, and basic CGMP compliance.
Areas Covered in the Webinar:
Who Will Benefit:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, 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, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.
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