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

    /Dr. Rossano  /V. Geraldspeaker of compliance global
    Speaker: Dr. Rossano V. Gerald
    Duration: 60 Minutes
    Product Code: 700696
    Level: Intermediate
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overview

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

why should you attend

As exporters, when exporting outside ofU.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 documentations that are required for exporting to a foreign port.  This Food and Drug Administration (FDA) has various multiparts’ that contain compliance documentation and procedures that are necessary in this international business in order facilitate entry of goods.

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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

Learning Objectives

Exporters, we must understand what are their exporting roles to determine the export certificate for FDA-regulated products. Also, exporters must address what is their responsibility when it comes to distribution and selling of their goods. Next, 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 that must be followedto meet the duty compliance processes, which could lead to legal challenges and delay of the exportation process in this marketplace.

WHO WILL BENEFIT

  • 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

SPEAKER

Dr. Rossano V. Gerald is an academic professor and founder of RVG International Consulting Firm, LLC. He has over thirty years of business experience in strategic management, marketing analysis, and supply chain management. Dr. Gerald is a veteran of the United States Army. He has worked with small and medium-sized businesses to help improve their business logistic processes through verification of operational and supply chain programs. Further, he has developed management and marketing strategies that were used to improve the efficiency and effectiveness of business operations in the global economy. He earned a Doctor of Business Administration in International Business and Advanced Professional Business Certification in Marketing from Argosy University/Sarasota; Master of Science Degree (J.S.M.) for International Tax and Finance Services in the risk compliance and management field from the Thomas Jefferson School of Law.

Dr. Gerald is 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, inventory planner and property forecaster, and certified consultant for business value analysis and methodology. He is also a certified export leader, certified master management consultant, certified CCA, certified marketing analyst and registered business analyst. He has published scholarly papers for the Journal of International Business and Economics and the Strategic Management Quarterly.

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