If you don’t know the answers to the following questions, you should attend the seminar:
· 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
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
This webinar is intended to help you get familiar with the Medical Device Reporting (MDR), Recall, Reports of Correction and Removals.
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.
This webinar is aimed at helping device industry understand how to establish procedures for MDR, recalls, corrections and removals and further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.
At the end of the webinar, you will get empowered in a way that you would plan, develop and execute the relevant procedures efficiently and effectively.
Areas Covered in the Session:
Review of Relevant Statutes and FDA regulations
Regulatory Requirements for MDR, Recall, Correction and Removal
How to Report A Medical Device Problem (MDR)
Reporting Requirements for the User Facilities, Manufacturers, and Importers
Recalls, Corrections and Removals (Devices)
Voluntary Recalls and Mandatory Device Recalls
Corrections and Removals
Enforcements: Case Studies
Who will benefit: (Titles)
· 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
Anyone interested in the topics
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 FDA’s 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.
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