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FDA's New Import Program for 2018 - Strict Precision: 2-Day In-Person Seminar by Ex-FDA Official

ComplianceOnline

Thursday, June 21, 2018 at 8:30 AM - Friday, June 22, 2018 at 4:00 PM (PDT)

FDA's New Import Program for 2018 - Strict Precision:...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird price)
(Registrations till May 14, 2018 - $1199)
Ended $1,199.00 $0.00
Seminar One Registration Jun 21, 2018 $1,499.00 $0.00
Group Registration
Special Group Discount Register for Six attendees
Jun 21, 2018 $5,999.00 $0.00

Share FDA's New Import Program for 2018 - Strict Precision: 2-Day In-Person Seminar by Ex-FDA Official

Event Details


Importing products regulated by the FDA has become more complicated. The FDA is using increasingly strict criteria. In order to ensure that your imported product does not get detained or refused entry, you should be knowledgeable about FDA requirements for foods, medicines, medical devices, cosmetics and radiation emitting devices. In addition, there are import requirements that are enforced by U.S. Customs and Border Protection (CBP) and intersect with the FDA’s legal requirements.

When products are detained, the situation becomes a very costly problem, and a firm needs to know what its options are and how it will resolve the detention quickly. Detentions can hold up a product for months only to have it re-exported or destroyed at your expense. The FDA’s use of automatic detention procedures makes it increasingly difficult to conduct an import business. A foreign manufacturer may receive a “Warning Letter” from the FDA or an inspectional “483.” You need to know how a FDA regulatory action affects your import business and what to do before that action dries up your import pipeline. Understanding all of these and other issues related to product detentions and how to deal with it, how US customs laws and FDA laws intersect etc. is critical to a firm’s successful import business and help reducing the commercial disadvantages it creates.

With what you learn in this seminar, you can work more productively and mitigate the risk of FDA detention. A high-ranking ex-FDA insider will give you straight talk on how FDA operates and the agency’s mindset. You will learn practical information, such as how to interact with FDA, the options you have to resolve problems and how you can prevent problems in the first place.

Learning Objectives:

  • Provide clarity to the FDA import program and process;
  • Understand how U.S. Customs and FDA laws intersect;
  • Know how to manage foreign suppliers that make the products;
  • Understand the internal procedures the FDA follows for imported products;
  • Understand how and with whom to negotiate at the FDA;
  • Learn how you can mitigate the cost and risk of detention;
  • Learn how to avoid common and costly problems;
  • Develop practical ways to improve your import and export business;
  • Identify government programs designed to help;

 

Who will Benefit:

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.

  • Business Planning Executives
  • Regulatory Managers
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business Acquisition Executives
  • Owners of New or Developing Import/Export Firms
  • International Trade Managers
  • Import Brokers
  • Investors
  • Logistics Managers
  • Sales Managers

 

Topic Background:

FDA’s import and export program is complex and keeps changing. The FDA’s and the U.S. Custom’s new import and enforcement program operates with a streamlined computer system and can leave 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 submit specific information to enter U.S. commerce.

Foreign establishments are subject to FDA inspections and quality testing. Failing either FDA activity typically prevents a foreign firm’s product from entering U.S. commerce. If product is detained, resolving the problem with FDA is time consuming, expensive and uncertain. Without an adequate or informed approach to your import program, the specialized federal government process and roadblocks can seem impossible to overcome. To compound the problems, working with foreign establishments presents inherent difficulties based on cultural differences business practices and language barriers.

Other foreign and domestic and legal requirements intersect with FDA’s import and export program, some for the better, some not. For example, not all foreign firms are treated the same under the FDA’s law. A clear example is the FDA’s uses of automatic detention based on the country of origin, type of product or an establishment’s history. With the growing use of off-shore operations, managing imported products can and does present obvious and hidden.


Speaker:

Casper (Cap) Uldriks

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

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.


For Registrationhttp://www.complianceonline.com/fdas-new-import-program-concerning-international-consequences-seminar-training-80133SEM-prdsm?channel=eventbrite          

 

Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

Have questions about FDA's New Import Program for 2018 - Strict Precision: 2-Day In-Person Seminar by Ex-FDA Official? Contact ComplianceOnline

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When & Where


DoubleTree by Hilton Hotel San Francisco Airport
835 Airport Boulevard
Burlingame, CA 94010

Thursday, June 21, 2018 at 8:30 AM - Friday, June 22, 2018 at 4:00 PM (PDT)


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Organizer

ComplianceOnline

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