Export Certificate for Medical Devices: Edge out Your Competition!

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jul 24, 2018
60 minutes
Product Description

Avoid Export Certificate Headaches and Smooth Overseas Exports

Have a medical device headed to overseas markets? If you goof up the export certificate you can be looking at delayed product approvals, slowed launches, and widespread public relations disasters. And it’s not just major mistakes you have to worry about—any error, even a minor one, can mean big disruptions. Full understanding and correct execution of the export certificate process has become a competitive advantage for global manufacturers of medical devices.

Join regulatory compliance consultant Angela Bazigos in this information-packed webinar as she guides you through the U. S. Food and Drug Administration’s (FDA) export certificate program.

The export certificate is the agency’s statement that the product meets U.S. laws and regulations, and it’s required by countries such as Norway, China, and Switzerland. “Certificates to Foreign Governments” are the most frequently requested type of export certificate, but you may encounter certificate requests when exporting devices under the Federal Food, Drug & Cosmetic Act—and when exporting non-clinical, research-use-only devices. In other words, there are plenty of scenarios in which you’ll need to get this paperwork right—and Bazigos will show you how. She’ll outline the key rules and insider strategies to get your product into the hands of overseas purchasers while keeping your records straight.

After attending this instructive session, you will understand how to properly choose a certificate type, submit an export certificate, and request certificate processing. Plus, Bazigos will equip you to use the FDA’s Center for Devices and Radiological Health Export Certification and Tracking System. Best of all, you’ll be positioned to edge out the competition and bring your device to an overseas market.

Session Highlights

Here is a taste of what this session will teach you:

  • The purpose of the export certificate program and its background
  • Use of export certificates by the FDA
  • Types of certificates, including the export permit
  • How to choose a certificate type
  • How to request processing
  • Record keeping best  practices
  • The FDA’s Export Certification and Tracking System

Who will benefit

  • Clinical Trial Physicians and Doctors
  • Managers and Directors of Regulatory Affairs, Quality Assurance, Clinical Research, Data Management, and Data Monitoring
  • Institutional Review Board members

Target Associations

  • Regulatory Affairs Professionals Society (RAPS)
  • Society for Quality Assurance (SQA)
  • American Society for Quality (ASQ)
  • Association of Clinical Research Professionals (ACRP)
  • American Medical Association
  • Society of Clinical Research Associates (SOCRA)
  • Drug Information Association (DIA)

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
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