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.
