2021 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Day 01(10:00 AM to 4:00 PM EST)
10.00 AM: Session Start
Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
Interaction of the Three Stages with Process Validation
Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
The Requirements of Phase 1 Investigational Drug Requirements
Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
Day 02(10:00 AM to 4:00 PM EST)
General Considerations for Process Validation – Stage 2 Process Qualifications
Special Considerations for Process Validation – Stage 2
General Considerations for Process Validation – Stage 3 Continued Process Verification
A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance
Concurrent Release of Process Performance Qualification (PPQ) Batches
Analytical Methodology and Process Validation; Warning Letter examples