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.
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:
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.
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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