Overview:
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance
Importing FDA regulated products requires careful planning before you
even start. Registration, product compliance, record and data
submission must be exactly correct or your product will be detained.
Likewise,
the U.S. Customs and Border Protection (CBP) must be precise or your
entry is not going anywhere. Some mistakes are common, others reflect a
lack of understanding of how FDA and Customs and Border Protection (CBP)
operate a joint program.
The logistics of importing products
complicates the process further and you must know the consequences of
your decisions. Some problems can cost you time and money, especially
when you do not work promptly with the FDA. If you end up with having
your entry "refused." There is no appeal. Then you face the possibility
of additional steep fines by CBP and be blocked from the U.S. market.
Why you should Attend:
Firms typically run aground with importing FDA regulated products
because they do not understand how to prepare, conduct and report
information in accord with FDA requirements. That mire of activity
starts before you even ship a product to the U.S. If the exporter and
importer do not follow the procedures or fail to submit correct
information, the road forward has an expensive and time-consuming toll.
A
failure to do things correctly will create a "bad actor" image, which
is very hard to undo and FDA does not forget, somewhat like a regulatory
elephant. It is true. If you understand FDA's and CBP's import program,
your business can operate in a competitive way. If you do not, your
customers, foreign suppliers, and stockholders will see the consequences
and not be forgiving.
Who Will Benefit:
- Regulatory Affairs Directors
- Software Designers / Specification Developers
- Production Managers
- Quality Assurance Directors
- In-house Legal Counsel