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FDA Compliance

Quality Systems Training
How to prepare for an FDA quality systems inspection
Disk 10
FDA Export Certificates
Video Length:
ID# DTA110
Price:
$145.00

Disk 10 of 10  (26 minutes)

You can buy the individual disks, or you can buy the complete training set for a 30% savings. 

CD of one of ten training sessions

Outline

  • Purpose of export certificates
  • Certification by requesters
  • Three types of export certificates
  • Export certificates
  • Certificate to Foreign Government (CFG)
  • Certify registration & listing
  • Certify compliance
  • Certify no HIV products
  • Manufacturer/distributor
  • Marketing status
  • Requestor information
  • Medical devices included
  • Certificate of Exportability (Section 802)
  • Why not a CFG?
  • Foreign manufacturers
  • Certification for 802
  • Not adulterated/contaminated
  • Meets purchaser specs
  • Labeled for export
  • Not sold in U.S.
  • Labeled per Tier 1 country
  • What are the Tier 1 countries?
  • Labeled per Sec. 802
  • Information for Sec. 802
  • Importing countries
  • Requester contact information
  • Devices covered
  • Can Class III devices be exported?
  • Security features
  • What do certificates look like?
  • Purpose of security features
  • Readily visible security features
  • Red letter & numbers
  • HHW gold foil seal
  • Less visible security features
  • FDA official’s signatures
  • What is a Notary Public?
  • Notary Public certification
  • USA - FDA
  • Certificate under ultraviolet light
  • Photocopies
  • Summary
  • Where can I find additional information?

System requirements

  • Windows XP (Service Pack 3), 7, 8
  • Internet Explorer 6 or later
  • Note:  This program will not run in Chrome, Firefox, or Safari.  It will not run on a Mac.  
DTA logo Produced for and in collaboration with the Dental Trade Alliance

 You can buy the individual disks, or you can buy the complete training set for a 30% savings.