Day One


I Packaging and Labeling: A Quality Management System

  • Provide an overview of packaging and labeling regulations
  • Analyze internal validation processes
  • Identify the scope of a packaging and labeling system
  • Review best practices that need to be adopted for Quality AssuranceII.

  • Session II cGMPs for Packaging and Labeling

  • Present current packaging and labeling principles, standards and regulations
  • Discuss manufacturing principles that will insure the identity, quality, potency and purity of your product.
  • Control practices for packaging labels including size, shape and color
  • Test procedures to ensure quality and control for packaging and labeling
  • Learn FDA approval standards and processesIII.

  • III SOPs for Packaging and Labeling

  • Guidelines presented for communicating and implement ing standardized procedures
  • Assure compliance and training qualications for employees and personnel
  • Determine standards for examination of issued labels and verication of used labels
  • Discuss procedures for both nished products and in-process systems

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