ONLINE WEBINAR 2017 - Quality Management Systems that Comply with ISO13485:2016
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Website https://www.onlinecompliancepanel.com/workshop/QUALITY-MANAGEMENT-ISO13485-2016-504371/JULY-2017-ES- |
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Category Quality Management, ISO 13485 2016, ISO 13485, ISO 13485 Training, ISO 13485:2016 Medical Devices, FDA’s UDI Regulation, FDA QSR, Quality Management System Compliance, ISO 13485 audit report, QMS success.
Deadline: July 20, 2017 | Date: July 21, 2017-July 22, 2017
Venue/Country: Aloft Minneapolis, 900 Washington Avenue South Mi, U.S.A
Updated: 2017-06-22 15:48:11 (GMT+9)
Call For Papers - CFP
AgendaDay 1 (8:30 am – 9:00 am: Registration Process)Anatomy of a Quality Management SystemACTIVITY : Create a QMS Outline and Identify Requirements in the StandardDetailed review of all Clauses within the StandardPolicies and Procedures designed to drive safety and complianceSupporting Documents and Databases covering operating procedures , staff training , and data managementOperational Procedures guiding regulatory compliance ,management involvement, and over all control of critical business functionsMonitoring and measuring of quality processes and operational outcomes affecting product quality and patient safetyCompliance and Improvement programs for audit ,inspection, and clinical informationGap Analysis of ISO 13485: 2003 to ISO 13485: 2016Increasing efficiency, cutting costs and monitoring supply chain performance through increased supplier controlsIncreased requirements for design controlCovering new requirements for complaint handling, regulatory reporting and unique device identificationApplication of RiskEnsuring all operational procedures are following a risk based approachDiscussion of risk mitigation techniques and implementationIdentifying ways to make medical devices safer and more effective.Day 2 (9:00 am : Workshop Start)Identification of Documentation RequirementsACTIVITY : Required Documents Search within the StandardUtilizing new Medical Device Files requirements for each family or line of devicesReporting requirements to regulatory authoritiesEnhancing product design and development through validation and design transferPreparing all necessary material for a Quality ReportMonitoring & Measurement of the QMSValidating software implementation into the manufacturing process and/or quality systemEstablishing evaluation procedures based on audit and quality reportsCreating a system of checks and balances to analyze QMS successCreating a Quality Plan for QMS UpdatesACTIVITY : Create a Quality Plan to take back with youObtaining senior leadership buy into the new programOutlining how to review and improve processes across your organizationUtilizing efficient reporting protocol and technologyIdentifying new or existing processes and documents affected by the changesEvaluating risks to the quality system associated with the QMS updates.Note: Use Promo code CG6KF and get 10% off on registration (Valid till JULY 31st 2017)
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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