Robust Verification and Validation



Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP requirements and U.S. FDA expectations. Robust CAPA requires a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality.

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, diseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events.

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 the “closed-loop” CAPA system.

A robust CAPA requires repeatable, systematic Failure Investigation and Root Cause Analysis. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for reslution 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.

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. 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 to be Covered:

Regulatory “Hot Buttons”
CAPA Background
Correction, Corrective Action, Preventive Action Defined
Impact Analysis and Response – a Key Component
CAPA System Assessment
Data Sources / Metrics
Monitor for Effectiveness
“Closed-Loop” – Lock In the Change
Beyond Regulatory Compliance

Who will Benefit:

This 90 minute in-depth webinar will provide valuable assistance to all regulated companies that need to review and modify their company’s CAPA system.

Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Senior management
Middle management
cGMP instructors
And all personnel involved in verification and/or validation planning, execution and documentation.

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 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 published 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.


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  • Presentation Handout in .pdf format
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