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CAPA, Failure Investigation

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. It 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 (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance. If inadequately performed it 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 the templates, tools and methodology presented in this webinar to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.Why you should attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT (devices) and ICH Q9 (drugs), underscore this increased emphasis. A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Areas Covered in the Session:Regulatory "Hot Buttons" The 4 Basic Steps to Problem SolvingA Suggested Investigation TemplateID / Document the Problem - CAPA, et alFailure Investigation / Analysis Methodology - And One Possible TemplateUse the 7 Tools to Find the Solution(s)Monitor for EffectivenessLock In the Change - Close the Loop Take It to the Next LevelWho Will Benefit:Senior management in Drugs, Devices, Biologics, Dietary Supplements QARAR&DEngineeringProductionOperationsConsultants; others tasked with product, process, CAPA resolution, failure investigation responsibilitiesJohn 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.Price: $245.00GlobalCompliancePanelNetZealous LLC,161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USAUSA Phone:800-447-9407Fax: 302-288-6884


8 May 2013 @ 10:00 am

8 May 2013 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar

Organised by

GlobalCompliancePanel (deactivated)

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