Import of fda regulated products into us

Import of FDA Regulated Products into the
US: FDA and Custom's Requirements at the
Port of Entry
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance
departments at Amarex Clinical Research, a full service CRO based in Germantown,
MD. His key expertise is in developing Global Regulatory Business Strategies for
biomedical product development and his passion is to bring traditional therapies for
India, China and the Latin-America to the Western markets. In addition to regulatory
expertise, Mukesh is an experienced auditor and a trainer in regulatory and business
processes.
Mukesh started his professional career as a research scientist at the NIH,
Baylor College of Medicine, Houston, and several premier institutions in India. With
more than 11 years of experience in virology, gene therapy, and molecular biology,
Mukesh has expertise in biological and combination products. He has been a global
Regulatory Affairs Specialist (US, EU, and India) for the last 5 years.

Description:
FDA and US Customs have special requirements for allowing entry of
regulated products. Regulated imports could be finished products for sales in the US
or raw material or components imported for use in manufacture in the US.FDA-regulated
products covered in this webinar include prescription drugs and biologics,
medical devices, over the counter drugs, dietary supplements, cosmetics, or medical
foods.
Importers are required to provide detailed documentation regarding the
compliance status of imported material, the country of origin, export documents from
the country of origin, the destination in the US, purpose of the import, registration
documents, chain of control, and several other elements. Incomplete, inadequate, or
erroneous documents are the most common reason for delays in the release or
refusal to enter at the US customs.

Why Should you Attend:
This webinar is intended for importers of FDA regulated products or those that
sell regulated products to the U.S. importers and wish to have a better understanding
of how FDA regulated products are entered into the U.S. Attendees will be introduced
to the customs entry process, customs bond requirements for regulated products;
HTS classification of regulated products; FDA import product codes; FDA affirmation
of compliance numbers and the FDA entry.
Attending this training will help you to better manage your import compliance
activities and help support your logistics supply chain.

Objectives of the Presentation:
The objectives of the presentation are to cover areas such as:
 FDA entry review process
 US Customs import documentation requirements
 US Customs bond requirements
 HTS classification of regulated products
 FDA import product codes
 FDA import affirmation of compliance codes
 FDA Prior Notice
 FDA ITACS system
 Role of US import agent
 Dealing with refusal to entry or delay in entry hold

Who can Benefit:
• U.S. importers of FDA regulated products
• Foreign exporters of FDA regulated products (companies which sell regulated products
to U.S. importers)
• Compliance officers
• Logistics/Supply chain managers and analysts
• Trade regulatory/legislative affairs professionals
• Sales/marketing personnel
• International business operations
• Customs or Trade Compliance Personnel or Officers
• Import or Global Trade Directors or Managers
• Import Supervisors
• Customs Brokers

Live Session - How it works?
• Username and Password will be sent to you 24 hours prior to the webinar
• Presentation handouts in pdf formate will be mailed to you
• Login to the session using the username and password provided to you
• Get answer to your queries through interactive Q&A sessions via chat
• Please let us know your thoughts and views at the end of webinar, your valuable
feedback will help us improve
• Get certification of attendance.
Recorded Session - How it works?
• A link will be provided to you upon purchase of the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be mailed to you
• Get certification of attendance.

Get Connected With Us:
www.onlinecompliancepanel.com

Import of fda regulated products into us

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