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Best Practices for Medical Device Reporting _MDR__ Recall_ Reports of Corrections and Removals


									 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 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?
Get 15 % Discount as a early bird                What are the regulatory requirements for
registrations. Use Promo Key :                   compliance to medical device reporting, recalls
 CGO15                                           and reports of corrections and removals?
                                                 What medical device adverse events are
                                                 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
                                                 Much more


                                            Areas     Covered      in    the     Session:       
                                             • Review of Relevant Statutes and FDA regulations
Live ( Single registration ) : $189.00      Regulatory Requirements for MDR, Recall,
Group ( Max 10 Attendee): $249.00            Correction and Removal
                                            Definitions
On Demand (Recording available):$289
                                            How to Report A Medical Device Problem (MDR)
Get Training CD : $449
                                            Reporting Requirements for the User Facilities,
Play back(Unlimited views):-309              Manufacturers, and Importers
                                            Recalls, Corrections and Removals (Devices)
    Who will benefit: (Titles)                       Voluntary Recalls and Mandatory Device Recalls
                                                     Corrections and Removals
        CEOs                                       Enforcements: Case Studies
    VPs                                             Conclusion
    Clinical affairs (associates, specialists,
    managers, directors or VPs)
    Regulatory        affairs    (associates,        .About Speaker
    specialists, managers, directors or VPs)
   Quality      professionals    (associates,
    specialists, managers, directors or VPs)          Dr. David Lim obtained his Ph.D. in biological sciences at
    R&D (engineers, scientists, managers,            the University of Missouri-Columbia and published his
    directors or VPs)                                 thesis research in the prestigious journal “Science.” Since
    Complaint and risk management
                                                      then, he has held various positions at Duke, US National
                                                      Laboratories, Intrexon Corporation, Terumo, US
    Consultants
                                                      FDA/CDRH, and EraGen Biosciences (A Luminex
    Anyone interested in the topics
                                                      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.
                      Compliance2go |
                      Phone : 877.782.4696 | Fax : 281-971-0286
                        Email :

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