Strategic Importing of FDA Regulated Products
Overview:
The presentation will cover all the regulatory steps involved in the importation of FDA regulated products as they apply to FDA and Customs and Border protection at the ports of entry.
FDA regulations and law applicable to your products will be covered and examples given of actual importations where things have gone wrong costing the importing company money and time. Advice will be given to the participants on what to do to avoid or minimize the impact of examinations, detentions and refusals.
Why should you attend: Learn to control your importation of FDA regulated products such as Foods, Medical Devices, and Drugs to avoid examination, detentions and refusals. Learn simple but effective techniques, to minimize the impact of FDA examinations during the import process. Learn how to deal with FDA-Customs-Customs Broker communication to speed up the release of your products for introduction into commerce.
Areas Covered in the Session:
- FDA Import Law
- FDA import regulations
- Logistics
- FDA Examination Process
- FDA Detention Process
- FDA Refusal Process
- FDA Warning Letters
- Untitled Letters
- FDA Hearing Process
Who Will Benefit:
- Regulatory Affairs Mangers
- Plant Managers
- Export/import Managers