Export Certificate for Medical Devices - Edge Out Your Competition!


Tuesday, August 28, 2018   |   10:00 AM PDT | 01:00 PM EDT   |   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 : 502050
  Instructor : Angela Bazigos

  More Trainings by this Expert


Overview:

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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.




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