Live Webinar on : Best Practices for Medical Device Reporting (MDR), Recall, Reports of

Corrections and Removals

Tuesday, July 03, 2012 duration : 01:00 to 02:00 PM EDT

Why should you attend :

If you dont know the answers to the following questions, you should attend the seminar:

Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

What are the applicable federal statutes and regulations governing medical device reporting, recalls and reports of correction and removals? What are the regulatory requirements for compliance to medical device reporting, recalls and reports of corrections and removals? What medical device adverse events are reportable? How to set the reportable criteria? How to report adverse events? How to establish the applicable procedures for MDR, recall, and reports of corrections and removals? Much more

Pricing Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Areas

Covered

in

the

Session:

Review of Relevant Statutes and FDA regulations

Get Training CD : $449 Play back(Unlimited views):-309

Regulatory Requirements for MDR, Recall, Correction and Removal Definitions How to Report A Medical Device Problem (MDR) Reporting Requirements for the User Facilities, Manufacturers, and Importers

Who will benefit: (Titles)

CEOs VPs Clinical affairs (associates, specialists, managers, directors or VPs) Regulatory affairs (associates, specialists, managers, directors or VPs) Quality professionals (associates, specialists, managers, directors or VPs) R&D (engineers, scientists, managers, directors or VPs) Complaint and risk management personnel Consultants Anyone interested in the topics .

Recalls, Corrections and Removals (Devices) Voluntary Recalls and Mandatory Device Recalls Corrections and Removals Enforcements: Case Studies Conclusion

.About Speaker

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, he has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDAs Transparency Public Meeting. Prior to founding his own consulting firm, Regulatory Doctor, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. 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. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, 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). He is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.

https://compliance2go.com/index.php?option=com_training&speakerkey=30&productKey=48
Compliance2go | www.Compliance2go.com Phone : 877.782.4696 | Fax : 281-971-0286 Email : Support@compliance2go.com