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    ONLINE WEBINAR 2017 - Quality Management Systems that Comply with ISO13485:2016

    View: 225

    Website https://www.onlinecompliancepanel.com/workshop/QUALITY-MANAGEMENT-ISO13485-2016-504371/JULY-2017-ES- | Want to Edit it Edit Freely

    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

    Agenda

    Day 1 (8:30 am – 9:00 am: Registration Process)

    Anatomy of a Quality Management System

    ACTIVITY : Create a QMS Outline and Identify Requirements in the Standard

    Detailed review of all Clauses within the Standard

    Policies and Procedures designed to drive safety and compliance

    Supporting Documents and Databases covering operating procedures , staff training , and data management

    Operational Procedures guiding regulatory compliance ,management involvement, and over all control of critical business functions

    Monitoring and measuring of quality processes and operational outcomes affecting product quality and patient safety

    Compliance and Improvement programs for audit ,inspection, and clinical information

    Gap Analysis of ISO 13485: 2003 to ISO 13485: 2016

    Increasing efficiency, cutting costs and monitoring supply chain performance through increased supplier controls

    Increased requirements for design control

    Covering new requirements for complaint handling, regulatory reporting and unique device identification

    Application of Risk

    Ensuring all operational procedures are following a risk based approach

    Discussion of risk mitigation techniques and implementation

    Identifying ways to make medical devices safer and more effective.

    Day 2 (9:00 am : Workshop Start)

    Identification of Documentation Requirements

    ACTIVITY : Required Documents Search within the Standard

    Utilizing new Medical Device Files requirements for each family or line of devices

    Reporting requirements to regulatory authorities

    Enhancing product design and development through validation and design transfer

    Preparing all necessary material for a Quality Report

    Monitoring & Measurement of the QMS

    Validating software implementation into the manufacturing process and/or quality system

    Establishing evaluation procedures based on audit and quality reports

    Creating a system of checks and balances to analyze QMS success

    Creating a Quality Plan for QMS Updates

    ACTIVITY : Create a Quality Plan to take back with you

    Obtaining senior leadership buy into the new program

    Outlining how to review and improve processes across your organization

    Utilizing efficient reporting protocol and technology

    Identifying new or existing processes and documents affected by the changes

    Evaluating 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.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.