U.S. Import of FDA Regulated Products: Understanding the Entry Process

Product Id : FDA42
Instructor : Dr. Rossano V. Gerald
Sep 06, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

Objectives of the Presentation:

  • How to manage the entry process to ensure import compliance and timely release of merchandise
  • Tips on classifying FDA regulated products
  • How to find an FDA import product code

Why Should you Attend:

U.S. Importers of FDA regulated products must know and comply with FDA and Customs' import requirements. They are expected to use reasonable care when making entry on their merchandise and be prepared to demonstrate compliance with U.S. health and safety standards.

Attend this webinar if you are importer of FDA regulated products or sell regulated products to U.S. importers and wish to have a better understanding of how FDA regulated products are entered into the U.S. Those new to importing FDA regulated products will also benefit from this webinar because we will explain some of the key terms, concepts and issues U.S. importers of FDA regulated products are likely to encounter. We will discuss the Customs entry process, Customs bond requirements for regulated products; HTS classification of regulated products; FDA import product codes; FDA affirmation of compliance numbers and the FDA entry.

Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.

Areas Covered in the Webinar:

  • Customs entry process
  • Customs bond requirements
  • Common U.S. Import documentation
  • Common U.S. trade terms and definitions
  • HTS classification of regulated products
  • FDA import product codes
  • FDA import affirmation of compliance codes
  • FDA Prior Notice
  • FDA ITACS system
  • FDA entry review process

Who will be Benefit

  • U.S. importers of FDA regulated products
  • New U.S. importers of FDA regulated products
  • Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
  • Purchasing department personnel for U.S. importers of FDA regulated products
  • Compliance officers
  • Logistics/Supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Sales/marketing personnel
  • Training personnel
  • Consultants
  • International business operations
  • Chief Executive Officers
  • Customs or Trade Compliance Personnel or Officers
  • Import or Global Trade Directors or Managers
  • Import Supervisors
Speaker Profile:

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 business logistic 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 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 certificate in Compliance & Risk Management from Thomas Jefferson School of Law in International Tax and Finance Services. He has also recently completed his MBA in Project Management from the University of Phoenix.

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 published scholarly papers for the Journal of International Business and Economics and the Strategic Management Quarterly.


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