CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

On-Demand Schedule Tue, October 04, 2022 - Tue, October 11, 2022
Duration 90 Mins
Level Basic & Intermediate
Webinar ID IQW19J1016

  • FDA’s and EU’s Emphasis
  • QSIT for a strategic, systems analysis of CAPA and high risk concerns
  • How to use your Risk Management Tools  (per Q9 and ISO 14971)
  • CAPA – a crucial series of risk-based lifecycle deliverables
  • Corrections and Risk
  • Corrective Action and Risk
  • Preventive Action and Risk
  • Closing the Loop
  • Management Review – tying it all together; taking it to the next level

Overview of the webinar

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.

Who should attend?

  • Regulatory Affairs
  • Quality Assurance
  • CAPA Administrator
  • Complaints Administrator
  • Manufacturing Engineer
  • Production Supervision
  • Senior Management
  • R&D

Why should you attend?

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

Faculty - Mr.John E. Lincoln

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.


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