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:
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
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.