Course Description:
At this workshop, Dr. David Lim will walk you through to get familiar with the following subject area.
Establishing Design Control for Medical Devices Including In Vitro Diagnostic Medical Devices (IVDs).
This workshop is intended to provide guidance on interpreting, understanding, establishing and maintaining design control for all classes of medical devices including IVDs.
During this workshop (October 31), defining, documenting and implementing design control procedures for medical devices including in vitro diagnostic devices will be discussed.
Why Should You Attend:
Understanding design control can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.
At this workshop, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices.
The following key areas will be discussed during workshop:
- Federal Statutes and Regulations Governing Medical Devices in the US
- Design Controls
- Introduction
- Design And Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification And Validation
- Design Evaluation Versus Specifications
- Software Validation
- Labeling Verification
- Design Transfer
- Design Changes
- Design History File
Who will Benefit:
This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, all classes of 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 research and development, quality, clinical and regulatory affairs and compliance.
This workshop is a must for those directly or indirectly involved in research and development, quality, clinical and regulatory affairs handling documentation for 510(k)s and PMAs. 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!
Course Outline:
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Meet Your Instructor
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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
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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
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)
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