OVERVIEW

Export Certificate for Medical Devices - Edge Out Your Competition! is organized by Compliance4All and will be held on Mar 20, 2019.

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 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.

Event Fee: One Dial-in One Attendee Price: US$150.00