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Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “510(k) Preparation, Submission, and Clearance”on October 3. David Lim, a certified professional for regulatory affairs (RAC) and a certified quality auditor (CQA); will be the speaker of this webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Description:This webinar will give insights on how to prepare a good 510 (k) that wins the approval of the FDA without too many hiccups and difficulties. 510 (k) is a critical requirement for premarket notification. Its documentation must be up to the prescribed mark for the device to achieve quality submission. A good 510 (k) preparation and submission paves the way for expediting the review process. The result of this is savings of millions of dollars for the company doing this. The 510(k) premarket submission is made to the US FDA to demonstrate that the subject device to be marketed is substantially equivalent, or is least as safe and effective to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3). In other words, the aim of 510(k) is to show that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has undergone quite a few changes, affecting the 510(k) decision-making process. It is necessary for medical device manufacturersto be aware of these changes. Their 510(k) submission should reflect an understanding and implementation of these recent changes. This expedites the review process and subsequent clearance. Using the CAC-SI method is one of the most potent ways of preparing for and submittinga 510(k), as it will facilitate the streamlined review of a 510(k). This is covered in this webinar. ----------------------------------------------------------------------------------------------------------------- When:October 3, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Dr. David Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). 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. Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Regulatory Affairs Managers, Directors and VPs o Clinical Affairs Managers, Directors and VPs o Quality Managers, Directors and VPs o Quality Managers, Directors and VPs o Compliance Managers and Directors o Sales and Marketing Managers, Directors, and VPs o Complaint Handling and Risk Management Managers and Directors o Site Managers, Directors, and Consultants o Senior and Executive Management o Compliance Officers and Legal Counsel o Business Development Managers, Directors, and VPs ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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online Training, CAC-SI method, US FDA, 510k Preparation, FD&C Act, 510k premarket submission,
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