- TypeWebinar
- Location Los Angeles, California, United States
- Date 25-06-2018
Education/Teaching/Training/Development
Administration/Management
OTHERS
Introduction
The 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. 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. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Why should you attend?
The new import entry filing requirements became effective in 2016 and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the frustrating task of contacting the FDA to resolve the problem. FDA’s software screening program, PREDICT, and U.S. Custom’s ACE program require careful attention. Errors will cost money. The less obvious software is the FDA’s and U.S. Custom’s linking of your legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. That sets up how FDA will apply its requirements. In addition, the information on the manifest, invoice and affirmation of compliance make importing easy provided you get it right. Making errors means FDA may flag you as a problem that requires greater scrutiny for data verification. As if delays and detentions are not bad enough, there will be punitive fines for filing incorrect entry data in ACE. This is a needless cost as long as you understand what you should be doing.
The benefits require the correct information for FDA and U.S. Customs software programs. At least now, using the PREDICT and ACE programs let you check the status of your entry and what the communications are between your broker and U.S. Customs. There is a lot of information at your fingertips now, if you get it right.
Learning Objectives
Areas covered in the Webinar
Who Will Benefit?
Speaker : David R. Dills
David R. Dills, Senior Consultant, Regulatory Affairs & Compliance NOVUSLIFE currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Time: 01:00 PM EST| 10:00 AM PST | Duration: 60 Minutes