Root Cause Analysis - Starting at the Beginning

John E Lincoln Instructor:
John E Lincoln 
60 Minutes
Webinar ID: 500521

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Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


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 the 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

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

Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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