BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T163914Z UID:9dd593d4-2128-44b5-8429-2d32eeaaac31 DTSTART:20210413T090000 DTEND:20210414T090000 CLASS:PRIVATE DESCRIPTION:
FDA and the Customs and Border Patro l Service (CBP) have become increasingly sophisticated and equally demandi ng in the submission of import information and adherence to government pro cedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed\, detained or refused. As of D ecember 2021\, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements o r face entry refusals and monetary penalties of up to $10\,000 per offense . Other factors can derail the expectation of a seamless import entry proc ess. The course covers detailed information about the roles and responsibi lities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will incl ude tips on how to understand FDA'\;s thinking\, negotiate with the FDA and offer anecdotal examples of FDA'\;s import program curiosities.
\n\nWhat happens when your product is detained? FDA will begin a legal process that can become an exp ensive business debacle. You must respond fully within short timeframes. T his is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.
\n\nThe FDA is steadily i ncreasing the legal and prior notice information requirements. If you do n ot know what those requirements are and you initiate a shipment\, your pro duct is figuratively dead in the water. You must be accurate with the impo rt coding information and understand the automated and human review proces s. If not\, you can expect detained shipments. CBP is implemented a new &q uot\;Automated Commercial Environment"\; computer program that changes import logistics and information reporting for FDA regulated products. Yo ur shipment may be stopped before it is even loaded at the foreign port. p>\n\n
When products are refused\, you have different options. Some opti ons may cost more than others. For example\, your product can be seized an d destroyed by the government. You may be fined if you do not act in a tim ely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.
\n\nL earn how to deal with common problems\, such as returns for repair\, impor ting QC samples\, and investigational products
\n\nOn a positive not e\, the FDA is implementing the Voluntary Qualification Importer Program u nder the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates\, for a modest fee\, which may give you a comp etitive advantage in foreign markets. In some cases\, a FDA export certifi cate is required by foreign governments. Finally\, the new EU Medical Devi ce Regulation will change how FDA manages foreign inspections and in your favor.
\n\nFDA Legal Authority Customs and Border Contr ol (CBP) Import Process FDA Import Process Registration and documentation< /strong>
\n\nFDA Import Process (continued )
\n\nImport Delays Import A lerts Detention Refusals
\n\nForeign Inspections FDA 483 - Inspectional Observat ions
\n\nFDA Warning Letters and Automatic detention
\n\nImport Hy pothetical FDA Import for Export Program FDA Export Program Export Hypothe tical
\n\nFDA Export Program Spec ial Import Issues
\n\nCasper (Cap) Uldriks \;owns Encore Insight LLC\
, which provides consulting services on FDA Law. He brings over 32 years o
f experience from the FDA. He specialized in the FDA'\;s medical device
program as a field investigator\, served as a senior manager in the Offic
e of Compliance and as an Associate Center Director for the Center for Dev
ices and Radiological Health. He developed enforcement actions and partici
pated in the implementation of new statutory requirements. He is recognize
d as an exceptional and energetic speaker. His comments are candid\, strai
ghtforward and of practical value. He understands how FDA thinks\, operate
s and where it is headed.
\n
\nPlease contact Marilyn Turner: Ph
one: +1 929 900 1853  \;Email: marilyn.turner [a] nyeventslist.com for
registrations