Strategic Importing of FDA Regulated Products

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

The presentation will cover all the regulatory steps involved in the importation of FDA regulated products as they apply to FDA and Customs and Border protection at the ports of entry.

FDA regulations and law applicable to your products will be covered and examples given of actual importations where things have gone wrong costing the importing company money and time. Advice will be given to the participants on what to do to avoid or minimize the impact of examinations, detentions and refusals.

Why should you attend: Learn to control your importation of FDA regulated products such as Foods, Medical Devices, and Drugs to avoid examination, detentions and refusals. Learn simple but effective techniques, to minimize the impact of FDA examinations during the import process. Learn how to deal with FDA-Customs-Customs Broker communication to speed up the release of your products for introduction into commerce.

Areas Covered in the Session:
  • FDA Import Law
  • FDA import regulations
  • Logistics
  • FDA Examination Process
  • FDA Detention Process
  • FDA Refusal Process
  • FDA Warning Letters
  • Untitled Letters
  • FDA Hearing Process

Who Will Benefit:
  • Regulatory Affairs Mangers
  • Plant Managers
  • Export/import Managers
Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.
He worked in numerous offices and held numerous positions such as Consumer Safety Inspector, Consumer Safety Investigator, Supervisory Consumer Safety Investigator, Drug and Device Specialist, Program Analyst and Diplomat. He was the first foreign- based FDA attaché in the United States Embassy in Mexico City, representing the FDA in all program areas.

With more than 28 years experience with the FDA Office of Regulatory Affairs, he knows how the agency conducts inspections in all program areas and how regulatory actions are developed within the agency and within the court system. He personally conducted numerous inspections and investigations resulting in legal actions by the agency.


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