CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, 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.
Areas Covered in the Session:-
Why You Should 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.
Who Will Benefit:-
Any Organization, Institution or Group User can register
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John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years of experience in U.S. FDA-regulated industries, 18 of which as a full-time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits, 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, and Regulatory Affairs, to the level of Director and VP (R&D).
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