GlobalCompliancePanel to organize RAPS pre-approved webinar on "Global Medical Device Adverse Event Reporting Systems in EU, Canada and US"

Top Quote GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on March 20 on the topic, "Global Medical Device Adverse Event Reporting Systems in EU, Canada and US". Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at this webinar. End Quote
  • San Jose, CA (1888PressRelease) March 20, 2013 - Description:
    Adverse event reporting is the second, but more important stage of a medical device manufacturer's task. The first stage is bringing the product out into the market after obtaining a marketing clearance, approval or certificates, but often, the second of these tasks is more challenging. Any adverse event from any of these products has to be reported to the authorities, such as the Competent Authorities in the EU, US FDA, and Health Canada and so on.

    Understanding and meeting requirements is the first step to meeting regulatory adverse event reporting standards. This webinar imparts useful information on how to meet these regulatory requirements and remain in conformity in the EU, Canada and US.

    This webinar will offer important information that will profoundly alter the way participants plan, develop, implement and follow the relevant and applicable processes and make it more efficient and effective.

    The expert will cover the following areas in this presentation:
    - Applicable and relevant regulations in EU, Canada and US
    - Definitions
    - Medical device adverse event reporting requirements in EU, Canada and US
    - Medical device vigilance system during the post-production phase in EU
    - Mandatory medical device problem reporting requirements in Canada
    - Mandatory medical device reporting requirements in US
    - Review of actual reporting forms in EU, Canada and US
    - Applicable and relevant guidance documents
    - Conclusion

    When:March 20, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    Dr. David 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 obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal, Science.

    Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products).

    In 2009, Dr. Lim served as a member during the FDA's Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail.

    For whom:
    The webinar will benefit
    - Regulatory Affairs Managers, Directors and VPs
    - Clinical Affairs Managers, Directors and VPs
    - Quality Managers, Directors and VPs
    - Quality Managers, Directors and VPs
    - Compliance Managers and Directors
    - Sales and Marketing Managers, Directors, and VPs
    - Complaint Handling and Risk Management Managers and Directors
    - Site Managers, Directors, and Consultants
    - Senior and Executive Management
    - Compliance Officers and Legal Counsel
    - Business Development Managers, Directors, and VPs

    Duration: 60 minutes

    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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