FDA Community Outreach Seminar

About this Seminar

Thursday, March 19, 2020
1:00 p.m. - 4:30 p.m.
Begin arriving at 12:30 p.m. to check in. Seminar is free, light refreshments will be served. Happy hour to immediately follow at the hotel lobby.

LOCATION:
Sheraton Valley Forge
480 N Gulph Rd
King of Prussia, PA 19406

PRESENTED BY:
Dawne Hines, Division Director of Northeast Imports, FDA
Dawne is responsible for over 100 investigations and compliance staff who ensure that the FDA regulated products entering the country through the airports, seaports, and International Mail Facilities from Maine to Virginia are in compliance with FDA regulations.

JoAnne Colonnello, CEE Director - Pharmaceuticals, Health & Chemicals
Director Colonnello serves as the Center Director for the Center of Excellence and Expertise for Pharmaceuticals, Health, and Chemicals (PHC) with U.S. Customs and Border Protection (CBP).  PHC imports into the United States totaled over $286 billion during fiscal year 2019.  The Center appraised over 5,000 shipments for seizure totaling $31 million and recovered over $24.5 million in anti-dumping duty. Before assuming duties as the Center Director, Ms. Colonnello served as the Assistant Port Director for the Trade Operations in the Port of New York/Newark.  Ms. Colonnello managed one of the largest trade divisions in the country responsible for the entry, classification, and appraisement of over $137 billion in merchandise and the collection of over $4 billion in duties, taxes, and fees.

TOPICS OF DISCUSSION:
2020 Regulatory Priorities
FDA Data Dashboard
FDA Required Data Elements
Testing Requirements
Importer Best Practices
FDA Organization Overview
CEE Overview
Section 301
Post Summary Corrections
Pharmaceutical Index

CONTACT:
Please contact Jessica Priestman with any questions you may have.

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