Online Training - Process Validation

OVERVIEW Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the FDA program “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A FDA Policy Guide of 2004 gave some hints to the new validation approach. In November 2008 the “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s current thinking. The chapter 1 of the EU GMP Guide gives hints for more emphasizes on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 from 2015 takes a life cycle approach to Process Validation nowadays. OBJECTIVE

• Understand how to set a risk-based process validation strategy and build into your documentation validation efficiency
• Clearly understand the expectations and how to comply with the US FDA threestage approach to Process Validation
• Clearly understand the expectations and how to comply with the PIC/S and EU approach to Process Validation, i.e. Annex 15 Qualification and Validation
• Understand the concepts of Continued Process Verification and Continuous Process Validation
• Understand how to establish and implement control strategies to maintain the validated state

COURSE OUTLINE

1. Why Validate?
2. International Regulatory Requirements
3. Science and Risk-Based Approaches
4. The 3 Stages of The Validation Life Cycle
5. Tools to Enable Effective Validation, such as:
   • Understanding Product and Manufacturing Process Requirements
   • Importance of Control Strategy
6. Readiness
7. Process Validation
8. Determining the Number of Validation Batches
9. Qualification of Equipment and Utilities
10. Maintaining Control and Monitoring of Product Life-Cycle
11. Analytical Validation
    • ICH Q2 Principles
    • Analytical Method Validation