Bullet-Proof CAPA

Why Should You Attend:

CAPA is one of four key CGMP areas the FDA targets in a compliance inspection. Often its key terms are not properly defined. And a Failure Investigation methodology and accurate Root Cause Analysis is key to many important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, Verification and Validation activities, CAPA, Audit corrective and preventive actions, et al. Simple tools are not understood, disseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events. The FDA has faulted companies repeatedly for CAPA problems -- failure to identify, systematically investigate, and then resolve the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system. Avoid a "shoot from the hip" approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods.

CAPA starts with accurate internal and external capture of problems. Then repeatable, systematic Failure Investigation and Root Cause Analysis. The most important CGMP area audited by the FDA is CAPA. It’s a company’s proactive problem resolution system. 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). 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.

Areas Covered in the Webinar:

• Correction, Corrective Action, Preventive Action defined.
• Key recent compliance problems and their resolution.
• Importance of Formal Failure Investigation and Root Cause Analysis to CGMPs, ISO 13485, ISO 9001, ISO 14971, and quality improvement initiatives.
• A Sample Failure Investigation Template.
• 7 Powerful Tools for Root Cause Analysis.
• Impact -- Often neglected but of major importance.
• Effectiveness -- Determining and Monitoring.
• Change – Implementation and Control.

Who Will Benefit:

• Senior and middle management.
• Quality Assurance
• Regulatory Affairs
• R&D
• Engineering
• Sales and Marketing
• Operations / Production
• Complaint Handling

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 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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