FDA's New Import Program for 2021

Recorded Webinar | Casper Uldriks | From: Aug 24, 2021 - To: Dec 31, 2021

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Recording
   $229  
DVD
   $249  
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   $389  
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   $229  
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   $379  
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Global commerce is at the mercy of the current COVID-19 pandemic. Firms’ must operate with the flexibility to cope with supply lines disruptions, port back-ups, and the availability of employees who can or will work.

Global commerce is at the mercy of the current COVID-19 pandemic. Firms’ must operate with the flexibility to cope with supply lines disruptions, port back-ups, and the availability of employees who can or will work.

FDA’s import program is complex, detailed, and changes without notice to the public. The FDA’s and CBP’s new import and enforcement programs operate with remarkable efficiency using software systems.

If an entry is detained, that will leave a firm scrambling for a resolution or suffer expensive consequences. If the FDA detains your shipment, you must resolve the problem under a 10-day deadline. On day 11, your product must either be destroyed or exported. That means you need to know the basic information and procedural requirements to avoid costly charges and fines.

Learning Objectives:-

  • 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
  • Know fundamental information required for entry
  • Understand FDA’s internal procedures
  • Learn how to mitigate and resolve import detentions

Areas Covered in the Session:-

  • Impact of COVID-19
  • Information required by FDA, CBP, and the U.S. Census Bureau
  • FDA’s entry procedures
  • Resolving import detentions
  • Foreign supplier 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

Casper Uldriks

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.