Corona Virus-19 Impact on FDA Imports

Casper Uldriks
Instructor:
Casper Uldriks
Date:
Friday, April 10, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 503001

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

FDA import operations have changed. Some will be temporary and some will be permanent.

The chain of events from the source of a product all the way to the final user or consignee must be reassessed and updated. As traumatic as the current circumstance is, you not only need to assess how you will cope with the current new risks, but how will you deal with this kind of scenario in the future with a different reason for alarm.

The webinar will walk you through risk factors you should consider. This is not only for protecting the value of your imported products, but the safety of the people involved from the beginning to the end.

The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and welfare of your customer base, which actually is the entire U.S. population.

In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.

Why should you Attend: What are your new risks and how can you mitigate their impact? What you do not know and do not mitigate as a risk factor will hurt, if not cripple, your near-term global import operations and recovery resilience.

If you do not have an emergency plan in place, you should establish and implement it immediately. You should plan on FDA's revising its import program, information requirements, foreign operations and risk management requirements in the U.S. The risks extend to your foreign manufacturer; port of loading; method and means on conveyance; management of your U.S. port of arrival; and U.S. distribution practices.

In each case, it will cost you more money if you have not planned to mitigate untoward barriers. You will have new problems with other federal agencies with overlapping jurisdiction. Your risk mitigation strategy needs to address a more complex maze of import operation and it must include partner government agencies, e.g.,Customs and Border Patrol Protection, U.S. Coast Guard, USDA, EPA and perhaps new entry requirements by state and local authorities. For example, how will you handle a quarantine of people on the ship that brought your product to the U.S. shore?

Areas Covered in the Session:

  • Foreign manufacturers (restrictions and FDA inspections)
  • Market impact
  • Product conveyance risks
  • Entry information and FDA's intensified risk assessment
  • Risks during transit
  • Port closures, port availability and ship quarantine
  • FDA entry review and release practices

Who Will Benefit:
  • Regulatory Affairs Directors
  • International Logistics Manager
  • Production Managers
  • Inventory Control and Warehouse Managers
  • Quality Assurance Directors
  • Marketing Managers
  • Medical consultants


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.


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