Foreign production of FDA-regulated goods and materials has exploded over the last decade. About 25 cents of every dollar spent by American consumers are on products regulated by FDA.
- FDA-regulated products originate from more than 150 countries
- 130,000 importers
- 300,000 foreign facilities
Statistics
- 20% FOOD: "15% of all food consumed by U.S. households is imported Approximately 50% of fresh fruits and 20% of fresh vegetables are imported 80% of seafood eaten domestically come from outside the United States." ~Food imports have increased an average of 10% per year from 2005-2011
- 80% DRUGS: 80% of API manufacturers are located outside the United States 40% of finished drugs are manufactured abroad Pharmaceutical product imports increased at nearly 13% per year.
- 35% DEVICES: At least 35% of all medical devices used in the United States are imported.
Our Courses
Learn how to import Foods into the United States
Learn how to import Drugs, Medicines into the United States
Learn how to import Medical Devices into the United States
- Online courses
- Community Engagement
- Practical knowledge
- For Individuals, Corporations, Schools and Trade Associations
- Small Businesses
Global Trade Food Imports $495
Course Regulatory:
Ready to import FOODS INTO THE UNITED STATES
According to the U.S. FOOD AND DRUG ADMINISTRATION
(FDA) Importing Food into the United States is a trillion dollars business. Over 20 percent of Food products consumed in the United States are imported by Small businesses, and which have been increasing 5-10 percent per year
Objectives:
- Students will obtain knowledge of the FDA Food facility Registration Objectives
- Understanding the Role of the U.S. Agent
- Identify the Permits and Certificates needed to import food products into the United States
- Understanding the laws of food packaging and labeling
- Producing a food product and the kitchen facility laws
- Planning your Imported Food Product: FDA Laws and Food Safety System, Good Manufacturing Practices (GMPs)
- Planning your Imported Food Product: FDA Laws and Food Safety Hazard Analysis Critical Control Points (HACCP)
- Planning your Imported Food Product: FDA Laws and Preventive Controls the Food Safety Modernization Act
- Exploring Job and Careers on Import/Export Trade and Course Assessment
Pharmaceutical Manufacturing Certificate Program $1,495
This course is designed to provide an introductory overview of manufacturing and applicable regulations in the pharmaceutical industry.
What this course Covers:
This 15-week course, students will gain invaluable insights from the expert on the FDA and regulatory affairs practices which they can apply.
Objectives:
- Students will obtain knowledge of the pharmaceutical manufacturing processes
- Distinguish between federal laws and Guidelines
- Describe Good Manufacturing Practices (cGMPs)on the pharmaceutical manufacturing
- Describe de Biologic de Biologics Control Act
- Explain what is US CFR Title of CFR contains regulations applicable to the FDA
- Explain the Quality Control (QC) Batch Release process
- State some of the essential features of packaging for pharmaceuticals
- Name some of the essential requirements of the weighing areas in pharmaceutical drug manufacturing following cGMPs
- Explain the functions of the Regulatory Affairs Department of a pharmaceutical company
- Define the terms: DQ, IQ, OQ and PQ
- Name and define each class of recalls
Biological Manufacturing Certificate Program $1,495
What this course Covers:
This 15-week course, students will gain invaluable insights from the expert on the FDA and regulatory affairs practices which they can apply
Objectives:
- Students will obtain knowledge of the pharmaceutical manufacturing processes
- Distinguish between federal laws and Guidelines
- Describe Good Manufacturing Practices (cGMPs)on the pharmaceutical manufacturing
- Describe de Biologic de Biologics Control Act
- Explain what is US CFR Title of CFR contains regulations applicable to the FDA
- Explain the Quality Control (QC) Batch Release process
- State some of the essential features of packaging for pharmaceuticals
- Name some of the essential requirements of the weighing areas in pharmaceutical drug manufacturing following cGMPs
- Explain the functions of the Regulatory Affairs Department of a pharmaceutical company
- Define the terms: DQ, IQ, OQ and PQ
- Name and define each class of recalls
Medical Devices Import $1,495
Ready to Import Medical devices Into the United States:
This 15-week course (one semester) students/participants will gain invaluable insights from the expert on the Import Operations practices which they can apply. 8-10 hours of self-paced learning per week, entirely online.
The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines that are used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for...
The U.S. medical device manufacturers market is estimated at USD 176.7 billion in 2020 and is expected to reach USD 186.5 billion in 2021. There are more than 6,500 medical device companies in the U.S., mostly small and medium-sized enterprises (SMEs). More than 80 percent of medical device companies have fewer than 50 employees, and many (notably innovative start-up companies) have little or no sales revenue.
Goals and objectives of the course, Ready to Import: The Complete Guide to Import Medical Devices into the United States:
- This course provides students with fundamental, practical knowledge of the global market and the import of Medical Device processes.
- Demonstrate understanding of new U.S. regulations regarding medical devices classes and designs all of its components, approval, 510k. There are 3 classes of medical devices: Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are intermediate-risk devices. Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV).
- Describe which devices requires FDA approval. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
- Demonstrate understanding of the steps required to import medical device products into the United States.
- Identify the Permts and Certificates needed to import medical products into the nited States.
Goals and objectives of the course, Ready to Import: The Complete Guide to Import Medical Devices into the United States
Identify new medical technologies and learn about:
- Virtual reality.
- Precision medicine.
- Health wearables.
- Artificial organs.
- 3-D printing.
- Wireless brain sensors.
- Robotic surgery.
- Smart inhalers.
- Inhalers are the main treatment option for asthma and if taken correctly, will be effective for 90% of patients.
Demonstrate understanding of the FDA Registration of a Medical Device facility , the role of the Agent, broker/filers, and the U.S. laws that governs them.
Demonstrate understanding of medical devices manufacturing and , current Good Manufacturing Practices (cGMPs)