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
credits towards a participant's RAC recertification upon full
Date & Time: Instructor Profile:
Thursday, June 28, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes Instructor: David Lim Chairman and CEO,
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
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
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.
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