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The FDA Medical Device Pre-Submission Program and FDA Meetings

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					GlobalCompliancePanel                                               Your Gateway to Regulatory Compliance

Live Webinar on

The FDA Medical Device Pre-Submission Program and FDA
Meetings

Date: Tuesday, December 3, 2013                                     Time: 10:00 AM PST | 01:00 PM EST

   Duration:    90 Minutes
   Location:    Online                                                          Register Now
 Instructor:    Albert A. Ghignone

Overview:
The FDA Medical Device Pre-Submission Program is intended for companies to obtain FDA feedback
on questions for future applications prior to their submission.

The submissions include Investigational Device Exemptions (IDE), Premarket Approval Application
(PMA), Humanitarian Device Exemption (HDE) and 510(k) applications.


Areas covered in the session:

    l   Understanding the FDA Medical Device Pre-Submission program
    l   How to prepare an FDA Medical Device Pre-Submission Package
    l   Types of FDA Pre-Submission meetings
    l   How to Request, Prepare For and Conduct FDA Meetings



Who Will Benefit:                                    About Speaker

                                                     Albert A. Ghignone
    l   Regulatory Affairs Professionals
                                                     Chief Executive Officer and President, AAG
    l   Quality Professionals                        Incorporated
    l   Clinical Professional                        Albert is the CEO of AAG Incorporated. For more
                                                     than 30 years his focus has been on FDA related
    l   Manufacturing Professionals
                                                     matters in regulatory affairs, quality assurance and
    l   Research Professionals                       clinical affairs. He has expertise in dealing with all
    l   Other professional that require an           aspects of the FDA approval process for drugs,
        understanding of the FDA Medical             biologics, medical devices and generic drugs. He has
                                                     worked in every major segment of the industry-
        Device Pre-Submission program
                                                     research, quality assurance,   ...more


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