Draft Guidance for Device Industry and FDA - Postmarket Surveillance (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Dec 08, 2011||End Date/Time: Dec 08, 2011|
Areas Covered in the Seminar:
- 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 be 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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