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Validity : 03rd May'24 to 13th May'24
Powerful Closed-loop CAPA - Meeting FDA Expectations
• Regulatory “Hot Buttons”
• CAPA Background
• Correction, Corrective Action, Preventive Action Defined
• Impact Analysis and Response - a Key Component
• "Bullet-Proof", "Closed-Loop" -- Lock In the Change
• Data Sources / Metrics
• Beyond Regulatory Compliance
Overview of the webinar
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) are major components of product complaint, non-conformance, and OOS failure investigations, and hazard analysis/risk management and mitigation activities, as well as product improvement. A compliant CAPA system is required to "close-the-loop" on complaints, non-conformances, out-of specification conditions, reduce “fire fighting”. It must include proper impact analysis/actions, another neglected aspect of CAPA.
As such CAPA is a major element of cGMP compliance (one of the four key inputs of QSIT, the FDA's Quality Systems Inspection Technique), and is also a key source of regulatory problems. A viable, pro-active CAPA system proves compliance to regulatory agencies more than any other CGMP component. How can scarce resources be allocated to activities that have the greatest impact to product quality/safety, minimize waste of resources, and still satisfy the regulatory agencies?
Who should attend?
Senior management
Middle management
QA/RA
R&D
Operations
Production
Engineering
Marketing
Why should you attend?
Expectations for meaningful, results driven, "bullet proof – closed loop" risk-driven CAPA (Corrective and Preventive Action) Systems that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason. EU’s ISO 14971 (Device Risk Management) and the FDA’s QSIT and ICH Q9, underscore this increased emphasis. A valid closed-loop CAPA system captures all sources of product problems and then utilizes root cause analysis for true problem (not symptom) resolution.
Growing high-profile field problems indicate that effective CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality/CGMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an integral part of a viable Quality Management/cGMP planning, implementation and execution system.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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.