PROCESS VALIDATION LIFECYCLE APPROACH

This one (1) day course will cover current thinking and approach to process validation. Current guidelines will be referenced, with emphasis on statistical applications and lifecycle approach to validation processes. References: PIC/S PE 009-14 (Annexes), ISPE Guides: Practical Implementation of the Lifecycle approach to Process Validation, Technology Transfer, Product realization by QbD, Process Performance and Product Quality Monitoring system, Determination of Number of PPQ batches Using Statistical Tool, Risk-Based Manufacture of Pharmaceutical Products. PDA Technical Reports: No. 60 Process Validation: A Lifecycle approach, PDA Technical 60.2 Process Validation: A Lifecycle approach.

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