CLEANING VALIDATION CURRENT APPROACH AND PRINCIPLES

This one (1) day course will cover current thinking and approach to cleaning validation. Current guidelines will be referenced, with emphasis on statistical applications and lifecycle approach to validation processes. References: PIC/S PE 009-14 (Annexes), PDA No.29: Points to Consider for Cleaning Validation. EMA Guides: Setting health-based exposure limits (HBELs) for use in risk identification in the manufacture of different medicinal products in shared facilities.

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