Preparing for an FDA API GMP Inspection 2014

Key Topics

• What are the causes of GMP violations and why do they exist
• What are the most important short term actions?
• Identifying critical reviews to perform
• What are long term activities that help prepare the organization to succeed?

Who should Attend

• Supervisory personnel responsible for any API functions
• API and Excipient producers and consumers (Drug Product Firms)
• Materials Management - purchasing, warehousing and distribution
• Quality Management
• Laboratory Supervision
• R&D personnel associated with API methods, validations, cleaning procedures, scale ups and specifications
• Functions that have an interest in becoming familiar with API GMP and its business impact
• Manufacturing chemists, Engineers