CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation and Root Cause Analysis – procedures and documentation. Allocation of scarce company resources for the greatest impact to product quality / safety. US and EU regulatory requirements. Since the US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be “risk based” – what this means, and how can this be implemented under CAPA. Internal and external complaints and CAPA. Trending. vA pro-active CAPA system is a major proof to regulatory agencies of a company in compliance and control.
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Changing a company’s CAPA system to a true risk-based closed-loop system results in a redistribution of scarce resources to activities that have a higher payoff in terms of reduced liability, both civil and regulatory, and improved product function and safety
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 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.