Setting Specifications & Assigning Acceptance Criteria for Potency Assay Release
Time: 11:00 am
day: Pre-Conference Workshop Day - Track B - Lunch
Details:
To ensure that consistency of production is maintained, some level of control is required to limit the variability of the product from batch to batch – this premise forms the basis of specification setting.
Attend to Discuss:
• Where to start when establishing a specification for a potency assay?
• How should you design your specification limits for release testing?
• How should you justify your specification limits to the FDA?
