Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and 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 also 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, not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize costly product quality problems.

Why should you 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 true 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.

Areas Covered in the Session:

• Regulatory "Hot Buttons"
• CAPA Background
• Correction, Corrective Action, 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

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