Successful Import/Export Programs

precon

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:15 a.m.

FDA Imports

  • FDA import history and pirates
  • Current legal authority
  • Registering and listing with FDA
  • Selecting an import broker
  • FDA’s and U.S. Custom’s dual role
  • Procedural fundamentals
    • Required notice
    • Required information
  • Documentation
    • Required and voluntary forms
    • FDA Form 2877
    • CPB Form 3461
    • Affirmation of compliance
    • Electronic filing

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

FDA’s Import/Export Technologies

  • FDA computer screening program (PREDICT)
  • U.S. Custom’s process and computer link to FDA
    • Harmonized tariff
    • Invoice and shipping records
    • Entry number and what it means
    • Bonded warehouses for possession/control
    • FDA’s notice of action and what to do
    • Sampling
    • Detention
    • Refusal
  • FDA computer tracking program (OASIS)
    • Internal database
    •  Violation codes

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Detention Process and Best Practices

  • FDA automatic detention/import alert list
    • Detention by
    • Country
    • Product type
    • Manufacturer
  • Options for detained products
    • Reconditioning procedures
    • Form FDA 766 — reconditioning agreement
    • RE-export
    • Destruction and added government fees

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Group Break Out Interactive Exercises

  • Import Hypothetical I — Technical Problems (short term issues)
    • What are your options if the FDA detains a product because the product code and other qualifier information is incorrect? What if the product requires a certificate of analysis? Who gets involved with the detention and what do they do? Many companies are either clueless or confused about what can to be done immediately to get the product released by the FDA. What is your plan of action? Will you wing it? What are your options for storage in the meantime and what can you expect with that?
  • Import Hypothetical II — Enforcement Problems (long term issues)
    • What are your options if the FDA detains your product because it is “filthy?” What are your options and what do you do? What if you tried to clean the product, but failed? Next, the FDA issues you a Notice of Action for refusal. What will the FDA do and what will you do next? Your next shipment of the same product is detained for the same reason. Your boss wants an explanation and how you are going to fix the problem. What is your game plan? Quitting your job is not an option.

4:30 p.m.

Session Wrap-up, End of Day One

 

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