Medical Devices: Reports of Corrections and Removals

What You Will Learn:
  • The key elements of 21 CFR Part 806
  • A method to determine when to submit a report to FDA
  • How other firms view their reporting obligations
  • How FDA views the reporting obligations


  • What You Will Get:
  • A copy of 21 CFR Part 806; the rule and the preamble
  • Warning Letters issued by FDA for violations under 21 CFR Part 806
  • An experienced and engaging faculty
  • Time for Questions and Answers


  • Expert Faculty:
  • Cap Uldricks, Special Assistant to CDRH’s Director of OC
  • Fran Akelewicz, Practical Solution, Inc.
  • Nancy Singer, Compliance-Alliance, LLC
  • Jim Handzo, Varian Medical Systems, Inc
  • Lisa Kaiser, Ethicon, Inc.


  • How it works:
    Each toll-free (even if international) dial in is $449; put the conference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout a few days before the conference. The materials may be duplicated for anyone attending.

    When:
    Wednesday October 26, 2005 from 1:00 pm to 2:30 pm EDT. (GMT -4)

    Where:
    In your office or conference room.

    To Register or for more information:
    For more information, or to register by phone, call FOI Services at 1-800-654-1147 (international registrants call +1-301-975-9400). To register online click the "Register for October 26" button in the main teleconference window. Click here to see our cancellation policy. For questions regarding the content of the conference, please contact Nancy_Singer@juno.com.

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