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Draft Guidance for Device Industry and FDA - Postmarket Surveillance  

Date & Time: Thursday, October 25, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: David R. Dills

Location: Online

Price : $245.00

 

  

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Instructor Profile:

Overview: This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance

David R. Dills Industry Regulatory & Compliance Consultant,

activities.

Areas Covered in the Session: l l l l

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Review proposed changes Explain the legal background and overview of statutory criteria Considerations regarding pediatric population provisions Understand expectations for postmarket surveillance study duration Describe the postmarket surveillance process and identification of issue Why an order for postmarket surveillance will issued under section 522 Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved Determine the elements to Include in a Postmarket Surveillance Study Plan

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Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions

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Current expectations for different stages of Postmarket Surveillance Study Reports Why happens if you fail to complete a Postmarket Surveillance Study.

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David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. ...more

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Who Will Benefit: The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by

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Regulatory Affairs Clinical Affairs Investigators Quality and Compliance Marketing & Sales

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Consultants

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Draft Guidance for Device Industry and FDA - Postmarket Surveillance