FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed inspection means that the FDA is likely to refuse the entry of the firm’s products. The webinar covers what FDA does and what you should do to prepare for an inspection, how you should manage the inspection as it takes place and what to do if you have problems. Firm’s that end up with inspectional observations or a Warning Letter have a lot of work to do in a very short time frame. The webinar will provide a “quick start” guide for what you should do to survive a regulatory disaster.
FDA’s import program has become complex and sophisticated. A successful import business requires a working knowledge of critical import requirements and what to do when a requirement is not met.
You will learn what the FDA regulatory hurdles are, how they work and how you can work with them in an efficient and effective way. You will also learn how the U.S. Customs and Border Patrol and FDA work in tandem.
Areas to be Covered:
How FDA prioritizes inspection assignments
How FDA prepares for inspections
A firm’s logistical preparation of an inspection
How to inter-act with the FDA on-site
How to respond to problems “observed” by FDA or a Warning Letter
How to manage import refusals and detentions
Who will Benefit:
Foreign Manufacturers and Holding Companies
Initial Importers in the U.S.
U.S. Initial Importers
U.S. Customs Import Brokers
International Regulatory Affairs Managers
Financial Planning Managers
Business Planning Executives
Business Acquisition Executives
Owners of New or Developing Import/Export Firms
International Trade Managers
Sales and Marketing Managers