What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries

This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products. Then, it also will discuss the FDA procedures that exporter must comply with in order to meet the Modernization Act agreement. Lastly, it explains what local government and private resources will have an impact on the exporter’s transaction process when it comes to tariff costs in an FDA trading environment.

Webinar Oct 17 2025, Friday 01:00 PM EDT 90 Minutes Intermediate Level Code: GRC0000313

  • Laws and Regulations
  • FDA Guidance
  • Definitions
  • FDA Process for Issuing Export Certificates
  • Export and Documentation Requirements
  • Important Information for Exporting FDA Regulated Products: Food, Cosmetics, Animal Drugs, Drugs, and Medical Devices
  • Regulatory Requirements Exported from the US
  • Prior Notice Process
  • How to Deal with Refusal to Issue Export Certificates
  • Common Misunderstanding and Key Considerations
  • Enforcement Actions: Case Studies
  • PASS-IT Recommendations: Best Practices

  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in the subject

As exporters, when exporting outside of U.S., then they must consider the Food and Drug Administration (FDA) provisions because it helps them to understand what documents and procedures are needed in the coordination transaction process. The Food and Drug Administration (FDA) measures will spell out the transportation documentation that is required for exporting to a foreign port. This Food and Drug Administration (FDA) has various multipart that contains compliance documentation and procedures that are necessary for this international business in order to facilitate the entry of goods.

Exporters, we must understand their exporting roles to determine the export certificate for FDA-regulated products are. Also, exporters must address what is their responsibility when it comes to the distribution and selling of their goods. Next, the exporter needs to know the determining factors for the origination of goods under the FDA Regulations. For this reason, exporters must be aware of their roles when it comes to generating the documentation and what procedures must be followed to meet the duty compliance processes, which could lead to legal challenges and delay of the exportation process in this marketplace.

RANDI WALTUCK BARNETT
RANDI WALTUCK BARNETT

Ms. Waltuck Barnett is a highly regarded global trade professional, having created and implemented global and domestic trade compliance programs across many industries for companies large and small. Her experience includes oversight of a $5B, 65-location division of Honeywell, a $3B, 17-location division of Motorola, and Global Trade Optimization for Dell, Inc., among others.

Ms. Waltuck has worked in the international trade arena in various industries for nearly 20 years. Her professional accomplishments include multi-million dollar global supply chain savings under various legal theories, as well as end-to-end global trade risk mitigation processes and procedures, identifying “right-sized” technology tools, including “compliance on a shoestring” practices.

She has served on councils and boards for various organizations, including the American Association of Exporters and Importers (AAEI), the Organization of Women in International Trade (OWIT), is a charter member of the International Compliance Professionals Association (ICPA), and a frequently sought-after trade and supply chain conference speaker for various well-known conference organizers, including the American Conference Institute (ACI), Marcus-Evans, and Richardson Conference Events.

  • 90 Mins | Nov 05, Wed , 02:00 PM EDT

Compliance in the tine of uncertainty and under current law & regulation

RANDI WALTUCK BARNETT By RANDI WALTUCK BARNETT

  • Oct 27, Monday | 01:00 PM EDT | 75 Mins

Tattoos were always associated with sailors, marines, and bikers. Not today. Over the past few decades, there has been r...

  • Oct 27, Monday | 01:00 PM EDT | 60 Mins

This webinar is for you if you ever find yourself in a difficult emotional situation where a cool head is necessary. Th...

  • Oct 27, Monday | 08:12 PM EDT | 90 Mins

Nisi earum est dicta ab perspiciatis expedita sint. Sint voluptatem deserunt autem rerum quia possimus ea asperiores. Fa...

By