Export Certificate for Medical Devices - Edge Out Your Competition!


Wednesday, March 20, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 90 Minutes          

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Duration: 90 Minutes  

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In this webinar you will learn Use of export certificates, Types of Certificates (including Export permit) , Also you will learn How to choose a certificate type , understanding and correct execution of the export certificate processes has become a competitive advantage for global manufacturers of medical devices.
Angela Bazigos   Product Id : 502352
  Instructor : Angela Bazigos

  More Trainings by this Expert


Overview:

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

The rules that companies must follow when exporting medical devices depend on whether or not their devices have been approved or cleared by the Food and Drug Administration.

Certificates to Foreign Governments are the most frequently requested type of export certificate, but export certificates may also be requested when exporting devices under sections 801(e)(1) and 802 of the FD&C Act or when exporting non-clinical research-use-only devices.

Why should you Attend: In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

In submitting export certificates, any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. Therefore, understanding and correct execution of the export certificate processes has become a competitive advantage for global manufacturers of medical devices.

Areas Covered in the Session:

  • Purpose of Presentation
  • Background
  • Use of export certificates
  • Types of Certificates (including Export permit)
  • How to choose a certificate type
  • How to request Processing
  • Record keeping
  • CDRH Export Certification and Tracking System (CECATS)

Who Will Benefit:
  • Clinical Trial Physician / Doctor
  • Manager to Senior Director of
    • Regulatory Affairs
    • Quality Assurance
    • Clinical Research
    • Data Management
    • Data Monitoring
    • Institutional Review Board


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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