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MAR
29

Foreign Manufacturing Facilities – Avoiding Problems with FDA

Conference
When the 29/03/12
Where Online Event
Description
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.

Who will Benefit:

This webinar will provide valuable assistance to
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Price $299.00

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Agenda for Foreign Manufacturing Facilities – Avoiding Problems with FDA

Areas Covered in the Seminar:

  • Findings of adulteration and creating new drugs – and resulting injunctions.
  • Manufacturing in compliance with current good manufacturing practices (CGMP).
  • Meeting the quality and purity characteristics required by FDA.
  • Facilities and controls used for the manufacture, processing, packing, or holding of drugs.
  • Equipment cleaning and record keeping.
  • Keeping batch production and control records for each batch of drug product.
  • Investigating unexplained discrepancy or the failure of a batch of drug products.
  • Assessing the stability characteristics of drug products and determining appropriate drug storage conditions and expiration dates.

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