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.
- Learn more about CQAs, CMAs and CPPs
- Learn how to perform clearance of impurities, worst-case studies and excursion studies
- Understand how to set-up a control strategy.
- Learn on risks related to raw materials, extractables/leachables from consumables and elemental impurities.
- Gain knowledge on th performance of stability studies related to process performance
Who should attend?
• Process development scientists and managers
• CMC development program managers
• Pharmaceutical development scientists and managers
• Manufacturing managers
• QC and stability control managers
• Heads of Quality Assurance
• Drug Regulatory Affairs managers