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

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

Wed, 28 Jul 2021, 01:00 PM

60:00 hours


USD 236


Softpath Systems Pvt. Ltd


Dr. Rossano V. Gerald

Webinar details:

Overview of the webinar

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 to meet the Modernization Act agreement. Lastly, it explains what local government and private resources that will have an impact on the exporter’s transaction process when it comes tariff costs in an FDA trading environment.

Why should you attend?

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 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 to facilitate the entry of goods.

Exporters, we must understand what their exporting roles are to determine the export certificate for FDA-regulated products. 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 determination 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.

Area Covered In This Session

  • 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

Instructor Profile: 

Dr. Rossano V. Gerald is an Academic Professor and Founder of RVG International Consulting Firm, LLC. He has over 25 years of business experience in, strategic management, marketing analysis, and supply chain management. Dr. Gerald worked with small and medium-sized businesses to help improve their business logistic processes through the verification of operational and supply chain programs. Also, he had developed management and marketing strategies that were used to improve the efficiency and effectiveness of his client business operations in this global economy.

He earned a Doctor of Business Administration in International Business and Advanced Professional Business Certification in Marketing from Argosy University/Sarasota; He also holds a Master of Science of Law (J.S.M.) degree and a certificate in Compliance & Risk Management from Thomas Jefferson School of Law in International Tax and Finance Services. He graduated with MBAs degrees in Project Management degree from the University of Phoenix and Webster University in Business Administration. He also earned a Graduate Certificate in Supply Chain Management at Penn State’s Smeal College of Business MBA Program. He is also a Certified Professional Coach (American Public University System).

Dr. Gerald is also a member of the Free Trade Alliance, San Antonio Transportation Association, Inc., San Antonio SCORE, TX, Supply Chain Council and Institute of Business Forecasting & Planning, and CATO Institute of Research & Analysis and Academy of Business Research. He is a Certified Supply Chain Manager, and Inventory Planner and Property Forecaster, Certified Consultant for Business Value Analysis and Methodology, Certified Export Leaders of the Free Trade Alliance and Casa of San Antonio, TX; Certified Master Management Consultant and Master Project Manager; and Certified Marketing Analyst and Registered Business Analyst by the International Management Consultant Certification Board (IMCB).

Who should attend:

R&D Scientists, Engineers, Managers, Directors, Regulatory Affairs, Quality Professionals, Product Development Professionals, CROs, Consultants, Senior Management, Contractors and Subcontractors