Course Description:
At this workshop, Dr. David Lim will walk you through to get familiar with the following subject areas.
510(k) Format and Contents
This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnostic devices.
Why Should You Attend:
Understanding regulatory requirements and submission quality of 510(k)s adequately addressing regulatory requirements will greatly facilitate the regulatory review process, leading to fast marketing clearance and saving millions of dollars to organizations!
At this workshop, you will get familiar with 510(k) submissions concerning medical devices including in vitro diagnostic medical devices.
The following key areas will be discussed during workshop:
- Federal Statutes and Regulations Governing Medical Devices in the US
- 510(k) Format and Contents for Various Device Types Including In Vitro Diagnostic Devices
Who will Benefit:
This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those who are involved in quality, clinical and regulatory affairs and compliance.
This workshop is a must for those directly or indirectly involved in 510(k) submissions. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.
The following employees who will benefit include:
- Regulatory affairs (associates, specialists, managers, and directors)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Site managers, and consultants
- Senior and executive management (VPs, SVPs, Presidents and CEOs)
- Contractors and subcontractors
- Anyone interested!
If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
- What are the applicable statute(s) and regulations?
- How do you identify and use necessary information for 510(k) filing purposes?
- How/when do you begin your interaction with the FDA?
- When do you submit a 510(k)?
- What happens if we fail to submit the 510(k) when required?
- What are the available types of 510(k)s and what are the differences in contents for each type of 510(k)?
- How to determine which 510(k) path is suitable?
- What factors to consider when choosing a predicate(s)?
- What are the pros and cons of bundling 510(k)s?
- What are clinical trial requirements, if applicable?
- What information/data is needed and how to put all the information together?
- How to interact before and during the review process upon submission?
- What to say and how to ask questions without being counter-productive?
- How do you resolve if differing opinions arise (e.g., IFUs)?
- What triggers FDA to hold the review process?
- What to implement for life cycle consideration of your products during post-marketing including labeling control and information dissemination through social media?
- Review and study of actual 510(k) materials/cases (FDA-cleared and disclosed)
- What/How to obtain competitors’ 510(k) documents?
- Much more!
Course Outline:
|
Meet Your Instructor
 |
Dr. David Lim Ph.D., RAC, ASQ-CAQ Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. 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 is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry. |
Register Now
Online using Credit card
|
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $100 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($100) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
Testimonials
What past attendees say:
I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair
My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager
I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager
I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst
Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs
All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director
ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer
Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)
|
Local Attractions
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity
