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

Why Should You Attend:

FDA measures will spell out the transportation documentations that are required for exporting to a foreign port. These regulations have various multipart that contain compliance documentation and procedures that are necessary in international business in order to facilitate entry of goods.

Exporters must understand their exporting roles to determine the export certificate for FDA-regulated products. They must address their responsibility when it comes to distribution and selling of their goods, and understand the determination factors for the origination of goods under the FDA regulations.

This webinar will guide exporters in their awareness of their role when it comes to generating the documentation required and in the 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, if handled without adequate knowledge.

It will also discuss FDA procedures that exporters must comply with in order to meet the Modernization Act agreement. Lastly, it will detail the impact of local government and private resources on the exporter’s transaction process when it comes tariff costs in an FDA trading environment.

Areas Covered in the Webinar:

• Export Requirements for FDA Regulated Products - Laws and Regulations
• FDA Guidance
• 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

Who Will Benefit:

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

Rossano V Gerald
Academic Professor, Texas A and M University

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 is a member of the Council of Supply Chain Management Professionals and has published several scholarly papers including one on NAFTA -Transportation Challenges: Case Study US-Mexico for the Journal of International Business and Economics.

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