Root Cause Analysis - Starting at the Beginning

John E. Lincoln
From: Nov 09, 2022 - To: Dec 31, 2022
Recorded Webinar


CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tools in product complaint, non-conformance, OOS failure investigations, and hazard analysis/risk management and mitigation activities.

A compliant CAPA system is required to "close-the-loop" complaints, non-conformances, and out-of-specification conditions, and must include proper impact analysis/actions. 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.

How can companies allocate scarce resources to those activities that have the greatest impact on product quality/safety, minimize resources on minor issues, and still satisfy regulatory agencies? Use the proper Failure Investigation and Root Cause Analysis methodologies to meet regulatory requirements and facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize costly product quality problems.

Areas Covered in the Session:-

  • Regulatory "Hot Buttons"
  • CAPA Background
  • Correction, Corrective Action, and Preventive Action Defined
  • Impact Analysis and Response - a Key Component
  • Failure Investigation and Assessment
  • Root Cause Analysis - Approaches and Tools
  • Data Sources / Metrics
  • Verify and Monitor for Effectiveness
  • "Bullet Proof" / "Closed-Loop" Lock In the Change
  • Beyond Regulatory Compliance

Why you should Attend:-

Expectations for a meaningful, results-driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies worldwide, with good reason.

Design Control (CGMPs and ISO), EU’s MDD / MDR, ISO 14971 (Device Risk Management), and the FDA’s QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for actual problem (not symptom) resolution.

Growing high-profile field problems indicate that effective, "closed-loop" CAPA is still not the industry norm. The billions of dollars spent by the industry annually on quality / GMP 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 viable Quality Management / cGMP planning, implementation, and execution systems.

Who Will Benefit:-

  • Senior management in Drugs, Devices, Biologics, Dietary
  • Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with product, process, CAPA resolution, failure investigation/root cause analysis responsibilities

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