Foreign Manufacturing Facilities – Avoiding Problems with FDA

This 90-minute webinar on compliant foreign manufacturing facilities will help you understand the problems that can occur with foreign manufacturers of pharmaceuticals. Recent inspections and enforcement actions by FDA have brought the topic into greater focus.

Why Should You Attend:

The FDA regulates foreign manufacturers of pharmaceuticals to be imported into the United States. Remote monitoring of quality assurance parameters can present challenges for foreign manufacturers in Central and South American and Asia. Failure to comply with FDA standards can lead to extremely large fines, enhanced scrutiny, and rigid monitoring. Proper determination of stability characteristics and expiration dates must be documented.

On occasion, the manufacturer may produce a batch of drug products that fail to meet a standard, or produce a discrepancy of some kind. How should this be handled? How should changes or deviations to standard operating procedures be handled?

This presentation will answer all of the above. You will understand the problems that can occur with foreign manufacturers of pharmaceuticals. We will discuss how consent decrees can be used to leverage FDA’s ability to collect data and monitor producers – both foreign and domestic.