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