2-Day Virtual Seminar

2-Day Virtual Seminar on Best Practices for Import & Export Control & Customs Compliance During & After COVID 19

Product Id : 11652
Casper Uldriks

Price Details

$1045.00 Recorded
$1395.00 Corporate Recorded
Refund Policy

Price Details  +

FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.  The FDA’s and CBP’s new import and enforcement programs operate with remarkably efficient software systems that can leave a firm scrambling for a resolution and end up suffering the expensive consequences of a detention.  The information data base used by the FDA includes extensive information from foreign suppliers.  If that is not in order, your shipment will not be permitted entry, in some cases even before the products can be loaded onto the vessel in a foreign port or before it arrives at the U.S. port.

Foreign establishments are subject to the same manufacturing regulations as U.S. firms.  There are inherent problems with foreign commerce, such as language and cultural differences.  If a foreign firm’s manufacturing operation or its products fail any criteria, a detention, or even worse, a refusal, becomes your next crisis.  If your product is detained, you must now how to try and resolve the problem with the FDA.  You have only ten days to figure out your plan and have FDA agree, which as not a given. On day 11, your product must either be destroyed or exported.  

FDA offers special programs to automatically release entries provided pre-qualification criteria are met.  This is especially valuable to importers of perishable goods. 

Import/export requirements can be confusing and costly if you do not understand the legal requirements.  You need clarity, accurate knowledge and solid business procedures to succeed.

Why you should attend

  • Identify and mitigate the impact factors of COVID-19 
  • Understand how the FDA’s and the CBP’s legal and administrative requirements intersect such as the Affirmation of Compliance and ACE.
  • You can understand FDA’s legal requirements and somewhat esoteric policies
  • Understand FDA’s internal procedures for import operations
  • Learn how to mitigate and resolve import detentions
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business
  • Learn how to interact with FDA and follow their procedures
  • Learn what happens to your if a foreign supplier is in trouble with FDA
  • Understand FDA export rules

Areas Covered in the Session

  • Impact of COVID-19
  • FDA’s legal authority and evidence threshold
  • Information required by FDA, CBP and the U.S. Census Bureau
  • FDA’s entry evaluation procedures 
  • Foreign supplier requirements
  • Products returned for repair
  • Imports of bulk pharmaceuticals, investigational products and research products
  • Export requirements and certificates
  • Import-for-export requirements

Who Will Benefit

  • Business Planning Executives
  • Regulatory Directors
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business acquisition Managers
  • Owners of New or Developing Import/Export Firms
  • International Trade and Logistics Managers
  • Import Brokers
  • Investors
  • Sales Managers

Agenda Day 1

Session 1 (90 Mins):

  • FDA legal requirements
  • Foreign manufacturers’ obligations
  • Selecting foreign suppliers 

Tea Break

Session 2 (90 Mins):

  • Foreign manufacturers’ obligations
  • Selecting foreign suppliers 

Lunch Break

Session 3 and 4 (90 Mins each))

  • Product Import Procedures:
  • Entry Process (FDA and CBP)
  • Customs House Broker
  • Documentation
  • Affirmation of Compliance
  • Electronic Filing
  • PREDICT screening program
  • Sampling
  • Detention
  • Quality Standards
  • Country of Origin
  • Product Type
  • Case Study


Agenda Day 2

Session 1 (90 Mins):

  • Detention
  • Options for detained shipments
  • Negotiating with the FDA and CBP

Tea Break

Session 2 (90) minutes

  • Detention (continued)
  • Release from Detention and Remedies
  • Reducing the risk of deterioration

Lunch Break

Session 3 (90 Mins):

  • Enforcement
  • U.S. FDA and Customs authority
  • Burden of Proof
  • Assistant U.S. Attorney
  • Government remedies

Tea break

Session 4 (90 Mins):

  • Special provisions
  • Counterfeit
  • Import for Export
  • International Trade Shows
  • Investigational Products
  • Compassionate Use

Speaker Profile
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Sign Up for Our Newsletter