Evaluating Best Practice for Analytical Technology Transfer Process to Ensure Smooth Transitions During Upscaling
Time: 3:30 pm
day: Day Two
Details:
- Understanding the GMP requirements during the technical transfer of analytical methods to enable effective upscaling
- Establishing robust methodologies for sharing protocols, custom reagents, and assay standards during tech transfer
- Discussing analytical methods to develop confidence in CQA preservation throughout manufacturing, storage, and shipment