Webinars >>FDA Regulations
How and When to Use a US Agent When Dealing with the FDA
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The US agent for a company is key connection a company has with the FDA. All companies are required to designate an authorized representative, also called a US agent, for communicating with FDA. The US agent is also the key contact for the US customs for any import and export related issues. For non-US companies, the US agent is generally a contractor or consultant who helps the client navigate US laws and prepare appropriate documentations for regulatory approvals and notifications. It is important to understand the role and responsibilities of the US agent for seamless operations in the US. Lack of US agent could add to the delays and even hold critical decisions from FDA regarding a company.
Why should you attend:
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This webinar will discuss the roles and responsibilities of US agents for US-based and non-US companies. The regulatory definition of US agent for different kinds of manufacturers, and locations will be discussed. The presenter will share case studies and examples from his experience acting a US agent for several US and non-US companies with the FDA. Best practices for selection, contracting, and supervision of US agents by client companies will be discussed. Rules for changing a US agent, reporting requirements, and eligibility conditions will be discussed. The seminar is designed as a comprehensive training to manufactures in all aspects of the FDA rules for US agents and practical tips for making the most of your US agent.
Areas Covered in the Session:
  • FDA definition of a US agent and its scope
  • Practical considerations for different kinds of products: drugs, cosmetics, devices, cosmetics, supplements, etc
  • SOPs needed for US agent tasks
  • Dos and don’ts for US agents
  • Suggested policies for interactions between US agents and FDA
  • Best practices for replacing US agents
Who will benefit:
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: September 5, 2018
​Duration: ​60 Minutes
​Time: 12PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com