Key GMP Systems in Pharmaceutical and Biotech Labs 2015

Key Topics

• FDA requirements for the equipment program
  
  • Equipment operation and maintenance
  • Equipment Qualification
• FDA requirements for OOS Investigations
  
  • CAPAs, Investigation Conclusion and Documentation of the Investigation
  • What are the Phases of an Investigation
  • Common pitfalls; 483s related to OOS investigations and lessons learned from them
• FDA requirements for method validation
  
  • Requirements for different method types
  • Overview of relevant ICH guidances and USP [1226]
  • S related to method validation and lessons learned
• FDA requirements for Pharmaceutical and Biologics Stability Programs
  
  • Stability study requirements for Phase I, Phase II and Phase III clinical studies
  • Overview of ICH and WHO requirements for Stability Programs
  • S related to Stability Programs and lessons learned
  • Stability methods and specifications

Who should Attend

R&D chemists, supervisors and managers, QC chemists, supervisors and managers, Regulatory Affairs personnel, QA Managers and personnel.