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Maintaining an Effective CAPA Program and Using Risk Assessment Tools.

Get an overview on the current trends in identifying recommended practices to improve, streamline, refine, retool, develop, deploy and maintain a viable and sustainable CAPA system.

OverviewCAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are. Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA training to help with the decision making process.Why Should You AttendThis webinar provides an overview on identifying recommended practices to improve, streamline, refine, retool and develop, deploy and maintain a viable and sustainable CAPA system. Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process, now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is.Areas Covered In This WebinarUnderstand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other risk assessment tools and quality problems and the use of appropriate statistical methodology where necessary to detect recurring quality problems. Learning ObjectivesHow to use FMEA training effectively and calculating Risk Priority Numbers: How to use the criteriaHow to facilitate a product complaint investigation as part of your CAPA programWhat is a closed-loop investigation…cradle to grave approachHow to conduct an investigation using a well-written CAPA policy and failure mode effect analysisUnderstand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutionsWhy risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practiceEstablish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisionsDevelop and deploy escalation rules and criteria to facilitate decision-making processUnderstand what it takes to conduct a “quality” investigation to ascertain the root causeReview and discuss recent CAPA red flags and FDA enforcement actions Who Will BenefitAll levels of Management for all DepartmentsQA/QC/CAPA CoordinatorsCAPA SpecialistsRegulatory Affairs and Compliance ProfessionalsEngineering/Technical Services/Operations PersonnelConsultantsLevelBeginner


15 Mar 2016 @ 01:00 pm

15 Mar 2016 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

AtoZ Compliance (deactivated)

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