Lecture 1: Process Validation – Overview
- Introduction, Goals and Objectives, Definitions
- Its Importance within the Industry
Lecture 2: Phases and Stages
- Interaction of the Three Stages with Process Validation
- How the two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3)
- Where do they merge?
- Do they exist independently of each other?
- Do they complement each other to enhance, build and provide a product?
Lecture 3: Phase 1, 2 and 3
- 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
Lecture 4: Stages 2 and 3
- 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
Lecture 5: EU Annex 15
- A Review of EU Annex 15
- Comparison to FDA’s Process Validation Guidance
Lecture 6: Process Performance Qualification (PPQ) Batches
- Concurrent Release of PPQ Batches
- Role of SOP in the company QM System
- How to deal with the established 3 batch approach?
Lecture 7: Analytical Methodology and Process Validation and Warning Letter examples