FDA and U.S. Customs and Border Protection are using new import requirements.The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. Take away is that the software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry’s commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports, which have been increasing by 5-10 percent per year for the last decade, and those percentages expect to keep rising. The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. The new import entry filing requirements became effective in 2016 and are posing problems for the user. Failure to provide the correct information creates costly delays. In some cases, you will need to contact FDA to resolve the problem.
Why should you attend:
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. The new import entry filing requirements became effective in 2016 and is posing problems for the user. Failure to provide the correct information creates costly delays.
The webinar focuses on FDA's software screening program, PREDICT, and U.S. Custom's ACE program that require careful attention for being prepared and compliant.
FDA’s required information for the PREDICT software screening prior to entry
• FDA product codes
• Custom’s required information for the ACE software system prior to entry
• Custom’s Harmonized Tariff Schedule (HTS)
• Affirmation of Compliance (AOC)
• FDA’s new cost-saving import programs
• Understand how U.S. Customs and FDA legal requirements intersect
• Know how to manage foreign suppliers
• Understand FDA’s internal procedures
• Learn how to mitigate and resolve import detentions
• Learn how to avoid common problems
• How do you deal with the FDA and the U.S. Customs and Border Patrol procedures?
• What happens when your product is detained?
• What happens if a foreign manufacturer is in trouble with the FDA?
Who will Benefit
This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies and biopharmaceutical companies preparing for FDA inspections. The employees who will benefit include:
- All levels of management and departmental representatives and any anyone who desires a better understanding of the new program from end-to-end and the ground rules
- Legal Counsel
- Regulatory Management
- Regulatory SME
- Regulatory Affairs/RA Specialists
- Technical Services/Operations
- Project Managers
- Business Planning Executives
- Regulatory Managers
- In-house Legal Counsel and Contract Specialists
- Venture Capitalists
- Business Acquisition Executives
- Owners of New or Developing Import/Export Firms
- International Trade Managers
- Import Brokers
- Logistics Managers
- Sales Managers
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty David R. Dills
David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.