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Validity : 14th Apr'24 to 24th Apr'24
Root Cause Analysis - Starting at the Beginning
- 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
Overview of the 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 to "close-the-loop" complaints, non-conformances, 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, 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.
Who should attend?
- 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
Why should you attend?
Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, 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 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 intregral part of viable Quality Management / cGMP planning, implementation and execution systems.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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, CAPA systems and analysis. 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 ptublished 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.