FDA Import Program with COVID-19
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He served field investigator, a senior compliance manager, and as the Associate Center Director for regulatory guidance and government operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program and helped develop FDA-wide policies in the import/export programs. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting and training service for FDA matters.
Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. 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 well fare 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.
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.
- 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
Course Level - Basic
Who Should Attend
- Regulatory Affairs Directors
- International Logistics Manager
- Production Managers
- Inventory Control and Warehouse Managers
- Quality Assurance Directors Marketing Manages
- Medical consultants
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.