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.
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 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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