Course Description:

During this course:

  • We will provide detailed information on FDA's authority and the requirements for FDA regulated products
  • We will review the proper forms (FDA and CPB) and learn how to complete them
  • We will do mock filings for FDA products to test our ability to prepare the entries correctly
  • Note: Participants will need internet access via a personal communicating device, preferably a lap top computer

Navigating FDA’s requirements in order to successfully import FDA regulated products is important for any company that relies on sales revenue from foreign made products regulated by FDA. In order to assure that the imported product does not get detained or refused entry the importer should be fully informed of FDA requirements for foods, medicines, medical devices, cosmetics, and radiation emitting devices. In addition there are requirements for general importation enforced by the Customs and Border Protection (CPB) section of the Department of Homeland Security.

What can happen if you are not familiar with FDA and/or CPB requirements? You may find that you have purchased a large amount of a foreign made FDA product, which do not meet FDA’s requirements. FDA may refuse entry, or you may incur a long delay in the importation, both of which can be very costly for the importer.

Learning Objective:

Key goals of the conference will include learning:

  • Become familiar with the product categories regulated by FDA
  • Know how to select foreign suppliers that can provide products that meet FDA requirements
  • Know the requirements for specific types of FDA regulated products
  • Become familiar with the procedures FDA follows to process an import entry
  • Know how to file FDA and CPB entries that will meet the requirements
  • Know who to negotiate with FDA when an import problem occurs
  • Know how to train your own employees in FDA/CPB requirements
  • Attain the ability to have a high level (100%) of success on each import entry

Who will Benefit:

Custom House Brokers and their employees who must file entries of FDA regulated products. For firms that import FDA regulated products, senior executives, directors, managers and those employees who have responsibility for selecting foreign products, filing FDA entries. Also regulatory consultants who want to offer assistance to firms who import FDA regulated products. as well as those that have key collateral roles in reviewing and/or preparing FDA submission documentation for food, drug and device firms, including officials from these areas within regulated companies:

  • Import Brokers and their employees
  • Regulatory Affairs persons for companies that import FDA regulated products
  • Marketing who will be selecting products to be imported
  • Contract laboratory personnel who will be assisting firms with analysis of imported FDA products
  • Legal Personnel for firms that specialize in FDA regulated product
  • Regulatory Compliance personnel

Course Outline:

Day One (8.00AM – 4.00PM) Day Two (8.30AM – 4.00PM)
  1. What is FDA?
    1. How does FDA do its job
    2. What is CPB and how do they do their job
  2. Specific Requirement for FDA regulated products
    1. Foods (Including Dietary Supplements)
    2. Drugs (Including Investigational drugs)
    3. Medical Devices (Including Investigational devices)
    4. Cosmetics
    5. Radiation Emitting Device
  3. Selecting foreign suppliers
    1. Inspection history
    2. Samples analyzed
    3. Vendor Audit
  4. The FDA Import Process
    1. Filing an entry
    2. Picking the right Custom House Broker

  1. Preparing Import Forms
    1. FDA Form 2877
    2. FDA Form 766
    3. CPB Form 3461
    4. Medical Device Affirmations of Compliance (AofC)
    5. Electronic Entry Filing
  2. The FDA Review Process
    1. Entry Review by FDA
    2. PREDICT entry review
    3. Field Exams and Sampling
    4. FDA Compliance Officer duties
    5. FDA Labs Sample Results
    6. Field Exam – Labels
  3. Negotiating Detained/Refused Entries with FDA
    1. What to say
    2. What not to say
    3. When to give up

Meet Your Instructor

Larry Stevens
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert

Larry is a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems; prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

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What past attendees say

I enjoyed this informational conference.
- International Regulatory Affairs Associate, 3M - Consumer Health Care Division

Conversation with other professionals was good and Larry had good discussion regarding real life FDA experiences.
- Quality Manager, Essential Ingredients Inc

Larry did a great job
- Quality Assurance manager, Arthur Schuman, Inc

It was good information for smaller importers.
- R&D Compliance, Abbott Nutrition

It was my first seminar and meeting the FDA expert (instructor). It is quite expensive but pretty worth it.
- Purchasing Agent, NONGSHIM AMERICA INC

Interaction with other attendees having similar issues and experiences was useful.
- Customer Care & QA Manager, DC Safety Sales

Media Partners


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Local Attractions

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