Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
Closed-loop Failure Investigation and Root Cause Analysis is a key part of a bullet-proof CAPA and CGMP compliance. It assures the FDA of a company's proactive CGMP system. Accurate and thorough Failure Investigation and Root Cause Analysis is key to successful CAPA, validation, and other problem-solving programs.
Simple tools and work flow are not understood, disseminated, and used consistently. Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools will be presented and discussed as simple and effective means to accomplish FI/RCA.
A breakdown in FI/RCA results in product failures, liability issues, scrap/waste/fall off, and needless recalls which appear on the FDA's website daily. Avoid a "shoot from the hip" approach — define, then attack, and resolve root problems/causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of a "closed-loop" CAPA system.
Code: FDB3751
Curriculum
Requirements
- Working in Medical Device, Diagnostic, Pharmaceutical, or Biologics fields
- Involved in quality assurance, regulatory affairs, production, R&D, or engineering
- No prior RCA training required — all tools are introduced from fundamentals
Who Should Attend
Senior Management, Regulatory Affairs Departments, Quality Assurance Departments, Production Departments, R&D Departments, and Engineering Departments in Medical Device, Diagnostic, Pharmaceutical, and Biologics companies.
Areas Covered
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 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, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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