FDA's New Import Program for 2018 – Are you prepared?

6 years ago Posted By : User Ref No: WURUR18335 0
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  • TypeWebinar
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  • Location Denver, Colorado, United States
  • Price
  • Date 08-03-2018
FDA's New Import Program for 2018 – Are you prepared?, Denver, Colorado, United States
Webinar Title
FDA's New Import Program for 2018 – Are you prepared?
Event Type
Webinar
Webinar Date
08-03-2018
Last Date for Applying
08-03-2018
Location
Denver, Colorado, United States
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Training Doyens
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Business Development

Food Processing

Location
Denver, Colorado, United States

OVERVIEW

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.

AREAS COVERED

  • 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?

LEARNING OBJECTIVES

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.

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
  • Purchasing
  • Quality
  • Auditors
  • Compliance
  • Technical Services/Operations
  • Project Managers
  • Consultants
  • 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
  • Investors
  • Logistics Managers
  • Sales Managers

 

For more detail please click on this below link:

https://goo.gl/huyWzf

 

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Others Details

Know about the new changes introduced by the FDA in its import program for managing issues along with the new procedures introduced to make the whole process better.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to audio recording of the webinar for 6 months. $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
  26468 E Walker Dr, Aurora, Colorado 80016-6104  Pin/Zip Code : 80016
Landmark
Colorado
Official Email ID
Contact
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

[email protected]

   7209961616
Training Doyens

26468 E Walker Dr, Aurora, Colorado 80016-6104

[email protected]

   7209961616    Fax No: Colorado City