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

  Product ID : GERA-0005

  Level : Intermediate

  Duration : 60 Minutes

Dr. Gerald is an Academic Professor and Founder of RVG International Consulting Firm, LLC. He has over twenty-five 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 logistics business processes through 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 also earned a Doctor of Business Administration in International Business and Advanced Professional Business Certificate in Marketing from Argosy University College of Business. He also holds a Juris Science Master of Law (J.S.M.) degree in International Tax and Finance Services and a Graduate Certificate in Compliance and Risk Management from Thomas Jefferson School of Law. He also has an MBA degree in  Project Management from the University of Phoenix and Management Operations from Webster University. He also was awarded Graduate Certificate of Supply Chain Management from Penn State, Smeal College of Business and a Certified Professional Coach from the American Public University System, Center for Teaching and Learning.

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).

Certified CCA ™ Chartered Compliance Analyst AAFM ® American Academy of Financial Management/Certified International Project Manager (CIPM) of the AAPM ® American Academy of Project Management. A member of the Council of Supply Chain Management Professionals; and an Advisor for the Mu Kappa Tau Marketing of the Honor Society. He has also published scholarly papers.

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 in order 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.

Areas Covered    

  • 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

Course Level - All three levels are being applied in the webinar

Who Should Attend

  • 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

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 in order to facilitate the entry of goods.

Exporters, we must understand what 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 distribution and selling of their goods. Next, 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 that must be followed to meet the duty compliance processes, which could lead to legal challenges and delay of the exportation process in this marketplace.

  • $200.00

Recorded / Download Access