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

By: Casper E. Uldriks, Former Associate Center Director of FDA's CDRH
Location :- Pyramid Club Philadelphia, PA
Thursday, August 23, 2018 | Friday, August 24, 2018
Location 2:- San Francisco, CA
Thursday, October 4, 2018 | Friday, October 5, 2018

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Course Description:

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, which will become mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage.

Learning Objectives:

  • FDA’s new cost-saving import programs
  • Understand how U.S. Customs and FDA legal requirements intersect
  • Know how to manage foreign suppliers
  • Understand FDA’s internal procedures
  • Learn how to mitigate and resolve import detentions
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business

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.

You will be able to answer the following questions with this course without saying, “I don’t know?”

  • What are the FDA’s import legal requirements and policy?
  • How do you deal with the FDA and the U.S. Customs and Border Patrol procedures?
  • What happens when your product is detained?
  • What happens if a foreign manufacturer is in trouble with the FDA?
  • How do you inter-act with the FDA to work out problems?
  • Why are import and export rules different or does it even matter?

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.

  • 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 problems.

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Day 1 / Morning

FDA’s legal requirements

  • Statutory authority
  • Regulations
  • Foreign manufacturers obligations
  • U.S. initial importers obligations
  • User Fees
  • How does FDA do its job
  • What is CPB and how do they do their job

Selecting foreign suppliers

  • Inspection history
  • Samples analyzed
  • Vendor Audit

Day 1 / Afternoon

Product Import Procedures

  • Entry Process (U.S. Customs/FDA)
  • How to Pick the right Custom House Broker
  • Documentation
    • FDA Form 2877
    • CPB Form 3461
    • Medical Device Affirmations of Compliance (AofC)
    • Electronic Entry Filing
      • FDA’s PREDICT computer screening program
      • Product sampling / testing
      • Detention, block list, automatic detention
        • Quality standards
        • Country of origin
        • Product type

      (Case Study)

Day Two (8:30 AM – 4:30 PM)

Day 2 / Morning

Detention

  • Options for a detained shipment
  • Negotiating with FDA and U.S. Customs
    • What to say
    • What not to say
    • When to give up
  • Release from Detention and Government Refusal Remedies
  • Reducing the risk of detention

(Group study for mitigating detention risks)

Day 2 / Afternoon

Enforcement

  • U.S. Customs and FDA authority
  • Burden of proof
  • Assistant U.S. attorney
  • Government remedies

Special provisions

  • Counterfeit
  • Import for export
  • International trade shows
  • Investigational device
  • “Compassionate Use”

Meet Your Instructor

Casper Uldriks_90x112
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.

Venue

Location 1:

Pyramid Club
1735 Market Street
BNY Mellon Center - 52nd Floor
Philadelphia, PA 19103, USA
Tel: +1 215-567-6510

August 23-24, 2018



How to Reach

General Driving Directions:

Driving directions from Philadelphia International Airport - 9.2 miles:
  • Get on PA-291 E/Penrose Ave from Garage Access Rd and Exit 13.
  • Continue on PA-291 E/Penrose Ave.
  • Take S 26th St and I-76 W to N 18th St. Destination will be on the right.
Select hotels close to meeting venue:
  • 300 feet | 1 min walk | Sonesta Philadelphia Downtown Rittenhouse Square | 1800 Market St, Philadelphia, PA 19103 | sonesta.com | (215) 561-7500 | $199/night
  • 0.2 mi | 4 min walk | Hotel Sofitel Philadelphia | 120 S 17th St, Philadelphia, PA 19103 | accorhotels.com | (215) 569-8300 | $395/night
  • 0.1 mi | 3 min walk | The Westin Philadelphia | 99 South 17th Street at Liberty Place, Philadelphia, PA 19103 | westinphiladelphiahotel.com | (215) 563-1600 | $214/night
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.
Location 2:
San Francisco, CA (Venue to be announced shortly)

October 4-5, 2018
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Seminar One Registration

August 23-24, 2018, Philadelphia, PA

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Seminar One Registration

October 4-5, 2018, San Francisco, CA
(Registrations till August 28, 2018 - $1299)
(Registrations after August 28, 2018 - $1499)

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Local Attractions of Philadelphia, PA:

Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit. Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space. Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

San Francisco, CA, Local Attractions

Think Escape Party Bus
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport.

Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino Tour San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity