Managing Foreign Inspections - Before, During and After

Duration: 60 Minutes
The importation of products regulated by FDA has grown steadily and will continue to grow. Manufacturing capacities, international economic growth and new markets drive global commerce and likewise the expansion of imports and exports. Over the past several years, however, problems with foreign manufacturers has become more evident and has prompted Congress and FDA to implement tougher import requirements.
The Bioterrorism Act
Instructor: Casper E Uldriks
Product ID: 500186
FDA’s inspection of foreign manufacturers is part of that effort. Some foreign manufacturers in the recent past created a public health concern in the U.S. due to the safety risks associated with their products. Inspecting foreign manufacturers is part of FDA’s attempt to reduce the public health risk posed by manufacturers that do not comply with FDA requirements. The Bioterrorism Act of 2002 placed the need for greater regulatory controls in the forefront to reduce the risks associated with foreign manufacturers and their products.

New federal laws require new controls. FDA has established a greater presence in geographic areas that produce goods that FDA regulates, such as China and India. With greater import controls, foreign facilities need to understand how they should manufacture their product in the first place. Otherwise, what follows loses its purpose.

FDA inspects foreign manufacturers to evaluate their compliance with manufacturing regulations, product quality, reporting requirements, establishment registration, product listing and FDA market authorization. The type of inspection conducted at a foreign manufacturer and the results of the inspection have a significant impact on a firm imports products into the US. If a manufacturer fails to comply with the applicable FDA requirements, it should plan on its products being detained or refused entry by FDA. That is a costly outcome for business.

Even managing a request for an inspection requires business planning, whether it is for a routine inspection, a follow up inspection for enforcement reasons or for obtaining authorization to market a new product in the U.S. After making arrangements for inspection, you should anticipate what FDA plans to review. That may be more predicable that you realize.

Managing the aftermath of a bad inspection places you in a very short time frame to respond effectively to FDA’s inspectional findings. Some inspections will be the basis for an enforcement action, such as placement on an Import Alert, which may delay or prevent the future importation of a foreign firm’s products. If FDA issues the foreign manufacturer a Warning Letter, the process and time involved in resolving the Warning Letter becomes lengthy, expensive, and complicated.

Why Should you Attend:
As FDA’s import requirements increase, planning and managing foreign manufacturing operations becomes critical. The regulatory bar has been raised for manufacturers. Some manufacturers can adapt. Some manufacturers may need work. Successfully importing products starts with a manufacturing operation that passes FDA muster. If not, the U.S. market can be closed to the firm. Managing FDA’s inspection is the first step you can take to mitigate the risk of FDA enforcement. Some steps are simple others require careful thought and planning. The course will cover management tasks that should be applied to any inspection of a foreign facility. Likewise, information about the foreign manufacturer is equally critical and should be well understood by those who play a role in your importing business.

Who can Benefit:
  • Initial importers in the U.S.
  • Foreign manufacturers
  • International regulatory affairs managers
  • Financial planning managers
  • FDA import enforcement consultant
  • US Customs Brokers
  • Business Planning Executives
  • 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
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Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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