BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T155000Z UID:07420ab0-f54b-4467-b2e8-4767c2ce2b6b DTSTART:20210323T083000 DTEND:20210324T083000 CLASS:PRIVATE DESCRIPTION:\n
 \;
\n\n***
LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
\n
 \;
\n\nYo u will be able to answer the following questions with this course without saying\, &ldquo\;I don&rsquo\;t know?&rdquo\;
\n\nSeminar Instructor Casper Uldriks is an & quot\;Ex-FDA Official"\; who has spent 32 years in FDA and his engagem ents focus on advertising and promotion\, recalls\, corrections and remova ls and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics\, including: FDA inspections\; import operations\ ; advertising and promotion\; corrective and preventive actions\; medical device reporting and corporate reorganization to improve conformance to th e FDA&rsquo\;s requirements.
\n \;\n\nThe FDA&rsquo\;s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. For eign manufacturers\, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA&rsquo\;s and the US Customs Border Patrol&rsquo\;s regulatory criteria\, inter-agency agreemen ts and intra-agency procedures. The conference provides attendees with the opportunity to understand their work&rsquo\;s inter-relationship with oth er attendees&rsquo\; roles.
\n\nFDA&rsquo\;s import and export program is complex and keep s changing. The FDA&rsquo\;s and the U.S. Custom&rsquo\;s new import and e nforcement program operates with a streamlined computer system and can lea ve firms at a loss to understand the short term and long term effects of a detained shipment. The law now requires foreign firms to register and sub mit specific information to enter U.S. commerce.
\n\nForeign establishments are subject to FDA inspection s and quality testing. Failing either FDA activity typically prevents a fo reign firm&rsquo\;s product from entering U.S. commerce. If product is det ained\, resolving the problem with FDA is time consuming\, expensive and u ncertain. Without an adequate or informed approach to your import program\ , the specialized federal government process and roadblocks can seem impos sible to overcome. To compound the problems\, working with foreign establi shments presents inherent difficulties based on cultural differences busin ess practices and language barriers.
\n\nOther foreign and domestic and legal requirements intersect with FDA&rsquo\;s import and export program\, some for the better\, some not. For example\, not all foreign firms are treated the same under the FDA&rsq uo\;s law. A clear example is the FDA&rsquo\;s uses of automatic detention based on the country of origin\, type of product or an establishment&rsqu o\;s history. With the growing use of off-shore operations\, managing impo rted products can and does present obvious and hidden.
\n