Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel

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Areas Covered in the Session:
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
Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions
Current expectations for different stages of Postmarket Surveillance Study Reports
Why happens if you fail to complete a Postmarket Surveillance Study
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All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:
Regulatory Affairs
Clinical Affairs
Investigators
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Legal Counsel
Consultants


Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884