GlobalCompliancePanel to conduct RAPS pre-approved webinar on

(prHWY.com) August 24, 2012 - Wilmington, DE -- GlobalCompliancePanel to conduct RAPS pre-approved webinar on "Successful 510(k) submission: Contents and Format"

Description:
Section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or simply the Act) is all about premarket notification requirements. This submission is made to the FDA to demonstrate that a device that is set to be marketed is as safe and effective as an already legally marketed device, or what is called a Predicate Device, and meets standards set out in 21 CFR 807.92(a)(3).
This understanding is critical to an organization because successful, first time 510 (K) submission can save it millions of dollars. Getting a step wrong, even at an advanced stage, will mean that the company has to start the whole process afresh.
Over the years, 510 (K) has evolved considerably. Medical device manufacturers need to be aware of the latest regulations and modifications of this requirement. This webinar will make it easier for companies to make 510 (K) submissions by familiarizing them with the changed guidelines. The aim is to facilitate a better understanding of the processes, so that participants' products get approved and do not result in huge expenses.
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When:September 26, 10:00 AM PDT | 01:00 PM EDT
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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.
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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
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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