Export of FDA Regulated Products from US to Other countries: Export Certificates and Other Documents

Date: On-Demand
Duration: 60 Minutes
Time: 12 PM EST

FDA issues about 7 different kinds of export certificates for products intended to the exported from the US to other countries. These certificates are needed for the importing country; without such certificates these products will not be allowed entry into the importing country. Many companies export not only products marketed in the US but also products that may not be legally marketed in the US but are allowed in other countries. For exporters of drugs, biologics, medical devices, diagnostics, food, and all other kinds products or components it is important to have an understanding of the documentation requirements, application process, expectations of the FDA, and the importing country to avoid delays due to custom clearance. Before FDA can issue an export certificate to a company, it requires detailed compliance documents and other paperwork from the applicant. Incomplete and inaccurate documents is the most common reason for delays and denials of export certificates.

This seminar will provide practical instructions in the process of getting export certificates from FDA including description of key terms, concepts, and common issues that exporters of FDA-regulated products are likely to encounter.  

Why should you attend:
This seminar is intended for exporters of FDA regulated products or those that sell regulated products to U.S. exporters and wish to have a better understanding of how FDA regulated products are exported from the U.S. Attendees will be introduced to the types of export certificates, conditions under which FDA issues or denies export certificates, legal requirements, fees, and regulatory requirements for export of FDA-regulated products from the US. Attending this training will help you to better manage your export compliance activities and help support your logistics supply chain.
 

Areas Covered in the Session:

  • FDA export certificate issuance process
  • US Customs export documentation requirements
  • FDA export product codes
  • Regulatory requirements for exported products
  • Prior Notice process
  • Role of US agent for exports
  • Dealing with refusal to issue export certificates

Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:

  • Exporters of FDA regulated products to other countries
  • Foreign exporters and importers of FDA regulated products (companies which buy regulated products for non-U.S. sales)
  • Compliance officers
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Sales/marketing personnel
  • International business operations
  • Customs or Trade Compliance Personnel or Officers
  • Export or Global Trade Directors or Managers
  • Export Supervisors
  • Customs Brokers
  • Companies interested in exporting US products to other countries for sales and reprocessing

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal. 

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com