Master a repeatable, systematic approach to failure investigation and root cause analysis — closing the loop on CAPA and building bulletproof GMP compliance that holds up under FDA scrutiny.
Includes live access & recording
Closed-loop Failure Investigation and Root Cause Analysis is a key part of a bulletproof CAPA and CGMP compliance. It assures the FDA of a company's proactive CGMP system. Accurate and thorough Failure Investigation and Root Cause Analysis is key to successful CAPA, validation, and other problem-solving programs.
It is also key to many other important cGMP activities — Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, and others. Such analysis is focused on systemic failures. Verification and Validation activities, Monitoring, Audit corrective and preventive actions, et al. are follow-on actions to assure the root cause(s) do not resurface.
Simple tools and workflow are not understood, disseminated, and used consistently. Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools will be presented and discussed as simple and effective means to accomplish FI/RCA.
A breakdown in FI/RCA results in the product failures, liability issues, scrap / waste / fall off, and needless recalls listed on the FDA's website daily. Avoid a "shoot from the hip" approach — define, then attack, and resolve root problems, not just symptoms, using repeatable, systematic, SOP-defined methods as part of a "closed-loop" CAPA system and basic CGMP compliance.
Closed-loop CAPA mandates a 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 resolution 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.
Consequently, the most important area audited by the FDA is CAPA — it assures the FDA that the company is in compliance without the Agency constantly auditing it. However, one of the most cited 483 observations is failure to resolve the key underlying problem and close out CAPA documents in a timely manner.
Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction, fewer recalls, and an improved bottom line.
By the end of this session, participants will be equipped to implement a repeatable, systematic RCA and CAPA methodology that meets FDA expectations.
Understand FDA's expectations for failure investigation and root cause analysis in CGMP-regulated environments.
Apply a repeatable, SOP-defined methodology for closed-loop CAPA systems that satisfy regulatory scrutiny.
Use powerful investigation tools including flow charts, Cause and Effect Diagrams, and the 5 Whys for effective RCA.
Accurately describe and document failures using a structured Failure Investigation Template.
Distinguish between root causes, probable causes, and symptoms to avoid symptomatic fixes that resurface.
Conduct impact analysis and define appropriate Correction, Corrective Action, and Preventive Action.
Determine and monitor CAPA effectiveness to verify resolution of root causes and prevent recurrence.
Institutionalize RCA practices to prevent entropy and sustain long-term CGMP compliance across the organization.
Four focused areas that will transform how your organization investigates failures and closes out CAPA.
Adopt a repeatable, SOP-defined investigation system that replaces "shoot from the hip" approaches with structured root cause identification.
Understand why CAPA is the most critical area audited by FDA and what commonly cited 483 observations reveal about investigation failures.
Master flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools that make FI/RCA simple, consistent, and audit-ready.
Build a complete CAPA cycle — from accurate failure description through correction, effectiveness verification, and institutionalization.
A comprehensive deep-dive across 9 critical areas of failure investigation and root cause analysis in GMP-regulated environments.
All regulated companies in Medical Device, Diagnostic, Pharmaceutical, and Biologics fields that need a repeatable methodology and powerful tools for closed-loop CAPA.
Senior Management
Regulatory Affairs Departments
Quality Assurance Departments
Production Departments
R&D Departments
Engineering Departments
Closed-loop Failure Investigation and Root Cause Analysis is a key part of bulletproof CAPA and CGMP compliance. It assures the FDA of a company's proactive CGMP system. Yet despite its importance, failure to perform adequate RCA remains one of the most cited 483 observations — reflecting a persistent gap between what organizations intend and what investigators actually find when they audit CAPA systems.
The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for resolution of the key underlying problem. Organizations that rely on ad hoc, inconsistent investigation approaches expose themselves to warning letters, consent decrees, and costly recalls that could have been prevented with a disciplined, repeatable system.
This session equips participants with simple but powerful tools — flow charts, Cause and Effect Diagrams, the 5 Whys, and other proven methods — to build a "closed-loop" CAPA system that defines, attacks, and resolves root problems rather than symptoms. The result is reduced product liability, lower costs, fewer recalls, and a quality system the FDA can trust without constant oversight.
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years of 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.
John has held positions in Manufacturing Engineering, QA, QAE, and Regulatory Affairs, up to the level of Director and VP (R&D). He has published numerous articles in peer-reviewed journals and conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis/management, FDA/GMP audits, validation, and root cause analysis. He writes a recurring column for the Journal of Validation Technology and is a graduate of UCLA.
Don't miss this essential training on systematic root cause analysis and closed-loop CAPA. Secure your spot and make your GMP investigations inspection-ready.