Foreign Manufacturing Facilities – Avoiding Problems with FDA 2012

Topics

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

Who should Attend

• Hazard Analysis Critical Control Point (HACCP) Coordinators
• Technical Directors / VP`s
• Pharmaceutical Quality Assurance Managers
• Pharmaceutical Operations / Production Managers