Draft Guidance for Device Industry and FDA - Postmarket Surveillance (Medical DeviceTraini)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Dec 08, 2011 End Date/Time: Dec 08, 2011
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This webinar will provide an overview and guidance to firms that are either going through or preparing to do postmarket surveillance activities. The training will cover expectations for Postmarket Surveillance Studies, the surveillance process, elements to include in a Postmarket Surveillance Study plan and expectations for different stages of Postmarket Surveillance Study Reports.

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.

NOTE : Use this Promocode (128600)to avail 10% discount,Valid till December 30 & add another webinar to your shopping cart and get 20% off on its price.


Online Event
2600 E. Bayshore Road
Palo Alto
United States