VIEWS: 27 PAGES: 2 CATEGORY: Medicine POSTED ON: 5/18/2012
This webinar is intended to demonstrate how submit a 510(k) and
get it successfully cleared from the FDA.
This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA.
Live Webinar on How to submit a 510(k) and get it cleared from FDA Course "How to submit a 510(k) and get it cleared from FDA" has been pre-approved by RAPS as eligible for up to 1.00 Register Now credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: Thursday, June 28, 2012 10:00 AM PDT | 01:00 PM EDT David Lim Duration: 60 Minutes Instructor: David Lim Chairman and CEO, Regulatory Doctor Location: Online Price : $245.00 (for one participant) Dr. Lim obtained his Ph.D. in biological sciences at the University Overview: of Missouri-Columbia and published This webinar is intended to demonstrate how submit a 510(k) and his thesis research in the prestigious get it successfully cleared from the FDA. journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, The section [510(k)] of the Federal Food, Drug, and Cosmetic Act Intrexon Corporation, Terumo, US (FD&C Act or the Act) describes the premarket notification FDA/CDRH, and EraGen Biosciences, requirements. The premarket notification [510(k)] is the most Inc., A Luminex Company. In 2009, common pathway to market for medical devices. The 510(k) Dr. Lim served as a member during premarket submission is made to US FDA to demonstrate that the the FDA’s Transparency Public subject device (to be marketed) is substantially equivalent (as least Meeting. Prior to founding his own a s safe and effective) to a legally marketed device (predicate device) consulting firm a s described in 21 CFR 807.92(a)(3). In other words, 510(k)s must (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of demonstrate that a proposed product is substantially equivalent to Scientific and Regulatory Affairs at another, legally marketed medical device that is also lower-risk and Aquavit Pharmaceuticals, Inc. in New is not subject to premarket approval (PMA). Over time, the 510(k) York, wherein Dr. Lim provided program has significantly evolved, affecting the 510(k) decision- inspiring and actionable solutions for making process. sustainable business operation. Dr. Lim as Regulatory Doctor provides To expedite the process of bringing a product to market through the practical, actionable and strategic 510(k) program, it is imperative the medical device makers solutions integrated with emotional intelligence (EQ) skills for all aspects understand the recent changes and be able to submit a 510(k) to of global regulatory, quality, clinical successfully clear it. and compliance matters. Over the years, Dr. Lim has analyzed over You will leave empowered at the end of the webinar in a way that 1,000 FDA warning letters. Dr. Lim you would submit your 510(k) using CAC-SI method, leading to your has also attended more than 50 FDA successful clearance of your 510(k). Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Why should you attend: Dr. Lim is familiar with more than Successful prosecution of your 510(k) submission can save millions of 200 medical products (medical dollars for your businesses. This webinar will discuss various devices including IVD products, biologics, drugs and combination circumstances, each of which will help you to prosecute your 510(k)s products). Dr. Lim is a certified better before the FDA. professional for regulatory affairs (RAC) and also is a certified quality Areas Covered in the Session: auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, l Applicable Statute(s) and regulations for 510(k)s consultant and instructor for global l How to identify a predicate device(s), if any. matters pertaining to regulatory l How to demonstrate substantial equivalence affairs and compliance, quality and l Recent changes in the 510(k) program. clinical affairs. ...more l Decision points during 510(k) review l Differences in contents of 510(k)s based on products l How to identify regulatory requirements relevant and Suggest a Topic More Webinars applicable to the product(s). l How to address the relevant and applicable regulatory Your Necessity is our Priority requirements. l How to present your performance data and clinical data in a succinct, comprehensive manner. l How to increase 510(k) submission quality for a product. Click here to register for this webinar 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 l Compliance Managers and Directors l Sales and Marketing Managers, Directors, and VPs l Complaint Handling and Risk Management Managers and Directors l Site Managers, Directors, 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 1000 N West Street Suite, 1200 Wilmington DE 19801 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
Pages to are hidden for
"How to submit a 510(k) and get it cleared from FDA"Please download to view full document