Preparing for FDA's New Import/Export Trauma in 2020
Former Associate Center Director of FDA's CDRH
Former Associate Center Director of FDA's CDRH
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage.
You will be able to answer the following questions with this course without saying, “I don’t know?”
Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals 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 the FDA’s requirements.
The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign 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’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles.
(Group study for mitigating detention risks)
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the 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. He 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.
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
For more details and other sponsorship options at this event, please contact Event Manager: firstname.lastname@example.org or call: +1-650-238-9656Media Partner:
Dallas World Aquarium lives up to its name, taking visitors on a global tour of nature and its stunning beauty. The Aquarium section includes species from around the world. Permanent exhibits include fish, jellyfish and coral from around the world. Visitors can walk through a special tunnel that runs through one of the large tanks, where sharks and manta rays swim about. The Dallas World Aquarium also features two gift shops and three restaurants.
The Sixth Floor Museum at Dealey Plaza seeks to inform visitors about the assassination of President John F. Kennedy on Nov. 22, 1963 as his motorcade drove through downtown Dallas and turned the fateful curve of Dealey Plaza at midday
The Dallas Museum of Art is an internationally recognized institution, showcasing an extensive collection that includes more than 23,000 works of art. You'll see extensive representations of African, Asian, Contemporary, Pacific Islands and European art.
The Dallas Zoo covers 106 landscaped acres and is open every day, except Christmas Day. Dallas Zoo is home to more than 2,000 animals, and today, the Zoo is thriving with new exhibits such as the Koala Walkabout presented by Kimberly-Clark Corporation, SOAR, A Festival of Flight, and the Giants of the Savanna to name a few.
Shop, dine, browse and enjoy great entertainment at the West End, Dallas' dynamic and original downtown shopping area. Now home to award winning restaurants, upscale nightlife spots and unique shops, the West End is a must see during any visit to Dallas.