Corona Virus - 19: New Risks with FDA Imports Logistics

Why Should You Attend:

Your import business plan requires updating now so you can effectively cope with the impact COVID-19 has on your FDA’s Import operations. Your regulatory and business operations must be updated for what will be moving target for safety. You need to consider a raft of issues to make it through this trauma. What are your issues 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 have not had an emergency plan in place, you should have one now. 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.

Areas Covered in the Webinar:

• 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
• Regulatory Affairs Directors for FDA and U.S. Customs and Border Protection
• Quality Assurance Directors
• Foreign Manufacturers and Foreign Exporters
• All FDA regulated Importers

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in 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. Mr. Uldriks 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. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Topic Background:

The Corona Virus – 19 (COVID-19) creates new business risks and problems for importing products that are under FDA’s jurisdiction. Business plans and importing logistics require a fresh assessment and implementation of new procedures for managing new risks, delays, unhappy customers and new expenses. Importing products will hurt your net profits if you do not mitigate the risks and related costs of risk management failure. Importers should have revised their import operations by now. Otherwise, your recovery will become needlessly expensive and slower that it should be.

FDA will be looking at information requirements and implement new import operations to reduce risks to health associated with the COVID-19.

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