This webinar is intended to demonstrate how to prepare a 510(k) in an adequate manner with increased quality for submission and subsequent clearance. The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification requirements.
RAPS Approved Webinar on 510(k) Preparation, Submission, and Clearance Date & Time: Course "510(k) Preparation, Submission, and Clearance" has been pre-approved by RAPS as eligible for up to 1.00 credits Register Now towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, October 3, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Instructor: David Lim David Lim Chairman and CEO, Location: Online Price : $245.00 (for one participant) Regulatory Doctor Dr. Lim obtained his Ph.D. in Overview: biological sciences at the University This webinar is intended to demonstrate how to prepare a 510(k) in of Missouri-Columbia and published an adequate manner with increased quality for submission and his thesis research in the prestigious subsequent clearance. 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 practical, actionable and strategic Areas Covered in the Session: solutions integrated with emotional intelligence (EQ) skills for all aspects l Governing statute(s) and regulations of global regulatory, quality, clinical and compliance matters. Over the l Definitions years, Dr. Lim has analyzed over l Device classification 1,000 FDA warning letters. ...more l How to identify a suitable predicate device(s), if any. l How to demonstrate substantial equivalence l Recent changes in the 510(k) program. l Decision points during 510(k) review Suggest a Topic More Webinars l Differences in contents of 510(k)s based on products Your Necessity is our Priority l How to identify regulatory requirements relevant and applicable to the product(s). l How to address the relevant and applicable regulatory 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. l How to respond to FDA’s request of additional information. l How to resolve different opinions between the submitter and FDA reviewer(s). 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. 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