A Webinar Series on Import Export Regulation for FDA Regulated Products

Duration: 60 Minutes
In order to export products from the US to other countries FDA issues about 7 different kinds of export certificates, without which the products will not be allowed entry into the importing country. FDA and US customs work closely to control the incoming and outgoing of regulated products using an intricate distribution of responsibilities and tracking systems.
Instructor: Mukesh Kumar
Product ID: 500841

Get practical instructions on the process of import of FDA-regulated products, how to get export certificates from FDA, common issues that exporters are likely to encounter, and how to meet the current requirements for dietary supplements. Our Import Export webinar series consists of 4 parts covering these areas.

Part-1: Import of FDA Regulated Products into the US: FDA and Custom's Requirements at the Port of Entry
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. 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 reasons for delays in the release or refusal to enter at the US customs. FDA-regulated products covered in this webinar include prescription drugs and biologics, medical devices, over the counter drugs, dietary supplements, cosmetics, or medical foods.

Objectives of the Presentation:
This webinar aims at providing in-depth knowledge on:
  • 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

*Note: Click Here to Register only for this Webinar


Part-2 Export of FDA Regulated Products from US to Other countries: Export Certificates and Other Documents
Many companies export not only products marketed in the US but also products that may not be legally marketed in the US but are allowed in other countries. For exporters of drugs, biologics, medical devices, diagnostics, food, and all other kinds of products or components it is important to have an understanding of the documentation requirements, application process, expectations of the FDA, and the importing country to avoid delays due to custom clearance. Before FDA can issue an export certificate to a company, it requires detailed compliance documents and other paperwork from the applicant. Incomplete and inaccurate documents are the most common reasons for delays and denials of export certificates.

This webinar is intended for exporters of FDA regulated products or those that sell regulated products to the U.S. exporters and wish to have a better understanding of how FDA regulated products are exported from the U.S.

Objectives of the Presentation:
This online training session aims at covering areas such as:
  • FDA export certificate issuance process
  • Types of export certificates
  • Conditions under which FDA issues or denies export certificates
  • US Customs export documentation requirements
  • FDA export product codes
  • Regulatory requirements for exported products
  • Prior Notice process
  • Role of US agent for exports
  • Dealing with refusal to issue export certificates

*Note: Click Here to Register only for this Webinar

Part-3 FDA Regulations for Importing and Exporting Medical Devices
FDA and US customs work closely to control the incoming and outgoing medical devices using an intricate distribution of responsibilities and tracking systems. Non-US importers must meet all applicable US medical device regulations in order to import devices into the US even if the product is authorized for marketing in another country. Many devices imported may not be approved for sale in the country of origin. The regulatory requirements include registration of manufacturing site, listing of devices, compliance with QSR, adverse events reporting requirements, and applicable market approvals such as 510(k) or PMA. One needs to designate a US agent and be subject to FDA audits. Similarly, exporter of medical devices both approved for marketing in the US and unapproved or investigational devices must provide compliance documents to FDA and customs. An exporter may need to request an export permit letter or export certificate, or it may need to submit a simple notification. Devices exported for research use only require the certificate of exportability. Exporters need to understand FDA electronic tracking system to request export documentations.

Objectives of the Presentation:
This webinar focuses on presenting detailed explanation on areas like:
  • FDA's processes of import and export of medical devices
  • Navigating the CECATS
  • Notification and Record Keeping Requirements
  • Regulatory requirements for medical devices intended for import and export
  • Prior Notice process
  • Role of US agent for import and export of medical devices
  • Dealing with refusal to issue export certificates and import permits

*Note: Click Here to Register only for this Webinar


Part-4 FDA Regulation of Dietary Supplement Imports into the US
In 2010, FDA published the final rule governing import of all dietary supplements into the US. This rule consolidated the previous rules for GMP, documentation, packaging and labeling, ingredient testing, and adverse event reporting requirements. The rules describe in detail the import and marketing requirements for all dietary supplements prior to importing into the country or getting into the US market, if manufactured domestically. Additional requirements such as Foreign Supplier Verification Program (FSVP) and third-party audit program have been proposed to further regulate the import of dietary supplements into the US.

This webinar is intended for manufacturers and importers of dietary supplements who wish to have a better understanding of how FDA regulates dietary supplements and the custom clearance requirements for such products. Attendees will be introduced to the various rules that apply to dietary supplements and how to navigate the Customs entry process. 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 learn about the:
  • Current rules of dietary supplement new ingredients
  • Documentation and labeling requirements
  • Facility registration for manufacturing sites
  • Import and domestic field exams
  • Import investigations and sampling
  • Role of US import agent
  • Dealing with refusal to entry or delay in entry hold

*Note: Click Here to Register only for this Webinar

Who Can Benefit:
  • U.S. importers of FDA regulated products
  • US Exporters of FDA regulated products to other countries
  • Foreign exporters of FDA regulated products (companies which sell regulated products to U.S. importers)
  • Medical device manufactures
  • U.S. importers of dietary supplements
  • Foreign exporters of dietary supplements
  • 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
  • Export or Global Trade Directors or Managers
  • Export Supervisors
  • Customs Brokers
  • Companies interested in exporting US products to other countries for sales and reprocessing.


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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. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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