ASTM 2500: Lessons Learned Through a Decade of Implementation 2019

Topics

• What is ASTM 2500
  • Concept
  • Definition
  • Differences from traditional validation approach
  • Requirements
• Regulatory Requirements for a Compliant Validation Program
  • EU
  • FDA
  • ICH Q8: Pharmaceutical Development
  • ICH Q7
  • Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
  • ICH Q9: Quality Risk Management
• Real World Examples of ASTM 2500 Implementation

Who should Attend

• Quality Assurance
• Operations
• Validation
• Quality Engineering
• Engineering