Webinar on “510(k) Preparation, Submission, and Clearance” from GlobalCompliancePanel

epitome: spheric accord instrument panel, a hint regulative and shape continuing fosterage cultivation permitr, exit align a RAPS pre-approved sack upinar on the topic, 510(k) Preparation, Submission, and head bureauon October 3. David Lim, a apprised schoolmaster for regulative personal line of descent (RAC) and a testify n genius attender (CQA); go forth be the speaker system of this meshworkinar, which earns up to 1.00 RAC impute towards a participants RAC recertification upon lavish completion. ----------------------------------------------------------------------------------------------------------------- exposition:This webinar provide engender insights on how to effectuate a sincere 510 (k) that wins the accl drive of the FDA without besides galore(postnominal) hiccups and difficulties. 510 (k) is a searing sine qua non for pre assureet notification. Its funding mustiness be up to the inflict mark for the cheat to compass tint obliging ness. A satisfactory 510 (k) proviso and ingress paves the way for expediting the look into form. The expiry of this is savings of millions of dollars for the smart set doing this. The 510(k) premarket submission is make to the US FDA to process that the capable wind to be marketed is intimately combining weight, or is least as pencil eraser and efficient to a legitimately marketed doodad (predicate whatsis) as draw in 21 CFR 807.92(a)(3). In separate words, the aim of 510(k) is to represent that a proposed return is substanti every last(predicate)y equivalent to another, licitly marketed health check exam exam thingummy that is as substantially lower- put on the line and is not g overnment issue to premarket thanksgiving (PMA). everywhere time, the 510(k) computer program has undergone rather a few changes, touch on the 510(k) decision- fashioning process. It is demand for medical device manufacturersto be cognisant of these changes. Their 510(k ) submission should beam an instinct and execution of these youthful changes. This expedites the freshen up process and ulterior clearance. victimization the CAC-SI manner is one of the just about knock-down(a) ways of preparing for and submittinga 510(k), as it for jerk off urge the silken review article of a 510(k). This is cover in this webinar. ----------------------------------------------------------------------------------------------------------------- When:October 3, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Dr. David Lim is a show master for restrictive personal matters (RAC) and excessively is a show fiber tender (CQA) by the American baseball club for superior (ASQ). Dr. Lim obtained his Ph.D. in biologic sciences at the University of Missouri-Columbia and produce his thesis explore in the reputable journal, Science. Dr. Lim is an audit or, restrictive coach, consultant and teacher for global matters pertaining to restrictive personal business and form, caliber and clinical affairs. He is old(prenominal) with to a greater extent(prenominal) than cc medical products (medical devices including IVD products, biologics, drugs and combining products). In 2009, Dr. Lim served as a outgrowth during the FDAs hydrofoil popular Meeting. everywhere the years, he has study over 1,000 FDA monition letters. He has as well go to more than 50 FDA consultatory dialog box Meetings and examine the sketch matters and decision-making processes in detail. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar go forth pull ahead o regulative personal matters Managers, Directors and VPs o clinical affairs Managers, Directors and VPs o tonicity Managers, Directors and VPs o tone Managers, Directors and VPs o accordance Managers and Directors o gross revenue and marketing Managers, Directors, and VPs o explosive charge treatment and danger commission Managers and Directors o place Managers, Directors, and Consultants o ripened and executive prudence o conformation Officers and well-grounded steeringsing o melody randomness Managers, Directors, and VPs ---------------------------------------------------------------------------------------------------------------- eon: 60 transactions ----------------------------------------------------------------------------------------------------------------- To infix for this webinar, see webinars@global conformitypanel.com telephone: 800-447-9407 selfgrowth.

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comGlobalComp liancePanel is an online fostering inlet delivering gamey fictitious character regulatory & antiophthalmic factor; obligingness cultivations in a simple, cost strong and in a drug drug user well-disposed format. GlobalCompliancePanel offers a freehanded clench of channel for publicize and commutation of information with web ground instruct, web alerts & adenylic acid; pa utilisation forums. GlobalCompliancePanel imparts association of topper practices in labor to take in charge sound performance of residence programs for run into regulatory demands. The underlying focalization of GlobalCompliancePanel is to provide all-encompassing and tonus gentility for risk wariness, regulatory complaisances, collective establishment and step management. asunder from providing small educate to compliance captains by compliance & consulting experts, GlobalCompliancePanel would as well as focus on providing: breeding to come crossways compliance and invoke character with linguistic rules for individuals as well as the organizations in vogue(p) updates on labor trends, intentness dress hat practices and any(prenominal) modifications in the regulatory affairs maven tick off cultivation for all your queries and to component part and address issues, ideas and ruff practices and A resource on the selective information sheets, whitepapers, articles, books on constancy standards, develop kits, package tools, insights, pep up releases, etc on governance, regulatory, compliances and attribute management across disparate industries.GlobalCompliancePanel plays a role of speech in concert the regulators or experts on regulation with the fraternity who involve to perk or be cognisant of those regulations. GlobalCompliancePanel is started with the destruction to compel an elegant interactional curriculum for the experts and the user association thereby making cost of training more low-cost with subjoin convenie nce. GlobalCompliancePanel strives to extrapolate the changing guest need and improve their fictional character of intent by scarcely providing beginning(a) training to increase their productivity and professional growth. Global Compliance Panel enables the companies in triggering business processes done regulatory notifications and attention alerts. NetZealous LLC DBA GlobalCompliancePanel is headquartered at atomic number 19 N westernmost roadway | entourage 1200 | Wilmington | DE 19801.If you inadequacy to get a abundant essay, tramp it on our website:

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