Manufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation comprises three main steps: (1) Stage 1 – Process Design (FDA) or Process Evaluation (EMA); (2) Stage 2 – Process Qualification (FDA) or Process Verification (EMA); and (3) Continued Process Verification (FDA) or On-going Process Verification (EMA). The training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.
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