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    Live web seminar Implementing an FDA-Compliant Medical Device Design Control Including DHF,DHR,and DMR

    View: 318

    Website https://compliance2go.com/product/?pid=CP2014-441 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: May 11, 2015 | Date: May 12, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-03-27 17:27:54 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar is intended to help you get familiar with an FDA-compliant design control system including a UDI system integration.

    Device manufacturers are required to establish and maintain the FDA-compliant design control system, where appropriate and applicable, as part of the quality management systems (QMS).

    Understanding, interpreting, and implementing design control requirements in a CAC-SI manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving an enormous amount of your unnecessary time and efforts including financial resources.

    This webinar will provide great opportunities to learn practical, actionable, and sustainable guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures applicable for all different types of medical devices including IVDs.

    At the end of the webinar, you will learn the best practices for design control requirements including DHF, DHR, and DMR and the UDI system integration in a manner you would establish and maintain the design control processes in a more efficient and effective manner.

    Why should you attend :

    This webinar will provide opportunities to get better familiar with an FDA-Compliant Design Control for Medical Devices Including In Vitro Diagnostic Medical Devices (IVDs).

    Areas Covered in the Session:

    Laws and Regulations Governing Medical Devices including IVDs

    Definitions

    Requirements for Design and Development Planning

    Requirements for Design Input, Design Output and Design Review

    Design Verification And Validation including Software Validation

    Design Transfer

    Design Changes

    Design History File (DHF)

    Device History Record (DHR)

    Device Master Record (DMR)

    Integrating a UDI System into the Design Control

    Speaker’s PASS-IT Recommendation/Suggestions

    Conclusion

    Who will benefit: (Titles)

    CEOs

    VPs

    Clinical affairs (associates, specialists, managers, directors or VPs)

    Regulatory affairs (associates, specialists, managers, directors or VPs)

    Quality professionals (associates, specialists, managers, directors or VPs)

    R&D (engineers, scientists, managers, directors or VPs)

    Complaint and risk management personnel

    Consultants

    Anyone interested in the topics

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Copy of PowerPoint slides (PDF print only)

    60 Minutes Live Presentation

    Certificate of Attendance


    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.