Root Cause Analysis - The Heart of a Successful CAPA Program.

John E. -Lincoln
Speaker: John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
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Duration: 90 Minutes
Product Code: 300001
Level: Beginner
Key Take Away

Get a proper understanding on how a valid closed-loop CAPA system requires Root Cause Analysis for true problem (not symptom) resolution.


Root Cause Analysis training is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis training/risk management and mitigation activities.

Root Cause Analysis process is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions, and do proper impact analysis/actions. As such RCA is a major element of cGMP compliance, and is also a key source of regulatory problems.

How can companies allocate scarce resources to those activities that have the greatest impact to product quality/safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce “fire-fighting” and minimize compliance problems.

why should you attend

Expectations for meaningful, results driven root cause analysis that addresses and resolves underlying product problems are increasing among regulatory agencies worldwide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis.

Areas Covered in this Webinar

A valid closed-loop CAPA training system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by 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 RCA as an integral part of CAPA, Validation and Quality Management Systems/cGMP planning, implementation and execution.

Learning Objectives

•  Regulatory "Hot Buttons"
•  The 4 Basic Steps to Problem Solving
•  A Suggested Investigation Template
•  ID/Document the Problem
•  Investigation/Analysis Methodology - The 7 RCA "Tools"
•  Find the Solution(s)
•  Monitor for Effectiveness
•  Lock In the Change - Close the Loop
•  Take It to the Next Level

Who Will Benefit

•  Senior management in Drugs, Devices, Biologics, Dietary Supplements
•  QA Professionals
•  RA Professionals
•  R&D Professionals
•  Engineering Personnel
•  Production Personnel
•  Operations Personnel
•  Consultants
•  Others tasked with Product, Process, CAPA Resolution, Failure Investigation Responsibilities

Speakers Profile
John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 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. 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 published 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.

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