Medical Device Quality Management Systems - Webinar By GlobalCompliancePanel by globalcompliancepane

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									                                                                      Toll Free Number: 800-447-9407


                                                                                        Live Webinar on


Medical Device Quality Management Systems

Date:Wednesday, February 20, 2013                                      Time: 10:00 AM PST | 01:00 PM EST

Course "Medical Device Quality Management                      Duration:       60 Minutes
Systems" has been pre-approved by RAPS as eligible
                                                               Instructor:     David Lim
for up to 1.00 credits towards a participant's RAC
recertification upon full completion.                          Location:       Online


                  David Lim
                  Chairman and CEO, Regulatory                             Register Now
                  Doctor

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his
thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke,
US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A
Luminex Company.    ...more

Overview:
his webinar is intended to help you get familiar with current Good Manufacturing Practice (cGMP)
requirements for medical devices including IVDs. This webinar is further intended to provide
guidance on implementing the cGMP requirements as set forth in the FDA Quality System
Regulations (QSRs), which help assure that medical devices are safe and effective for their intended
use.


Adequate interpretation and implementation of cGMP requirements compliant with FDA QSRs can
significantly contribute to achieving compliance fast, resulting in saving significant amount of
unnecessary time and efforts and, thereby bringing innovative medical products to the market
faster. This webinar will discuss Quality System (QS) regulations, requirements and how to achieve
compliance.

Areas Covered in the Session:

    l   Overview and review of the US QSRs for medical
        devices
    l   Flexibility of the QSRs
    l   Definitions
    l   Quality system requirements
    l   Management responsibility
    l   Audits
    l   Personnel
    l   Design control: design and development planning,
        design input, design output, design review, design
        verification, design validation, design transfer, and
        design changes
    l   Design history file (DHF)
    l   Device master record (DMR)
    l   Quality system procedures
    l   Purchasing controls
    l   Inspection, measuring and test equipment
    l   Process validation
    l   Corrective and preventive action (CAPA)
    l   Complaint files
    l   Servicing
    l   Quality requirements for premarket approval (PMA)
        application
    l   Enforcement actions: case studies
    l   Lessons learned



Who Will Benefit:

    l   Regulatory Affairs
        Managers, Directors and
        VPs
    l   Clinical Affairs Managers,
        Directors and VPs
    l   Quality Managers,
        Directors and VPs
    l   Quality Managers,
        Directors and VPs                 Suggest a Topic
    l   Compliance Managers
                                          More Webinars
        and Directors
    l   Sales and Marketing
        Managers, Directors, and
        VPs
    l   Complaint Handling and             Click here to
        Risk Management
                                         register for this
        Managers and Directors
    l   Site Managers, Directors,
                                              webinar
        and Consultants
    l   Senior and Executive
        Management
    l   Compliance Officers and
        Legal Counsel
    l   Business Development
        Managers, Directors, and
        VPs



It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.


For more information, please contact the event coordinator. We look forward to seeing you at the webinar.


Best regards,
Event-coordinator
GlobalCompliancePanel

About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
for online compliance training by creating a single window of learning opportunities for compliance
professionals & providing a forum for expert speakers/panelists to render their services through simplified
online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of
best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance
professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all
sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal
ensures a secure & cost effective online environment and also support your E-learning and development
on/through our website. Keep track of all webinars arranged for your industry through notifications & event
calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
Livermore Common, Fremont,
CA 94539, USA

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
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