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Process Analytical Technology (PAT) in Freeze DryingABSTRACT:The recent FDA Quality by Design (QbD) initiative and the pertaining PAT Guideline have initiated more intensive demand for process monitoring in freeze drying. Application of PAT is necessary for improvement understanding of manufacturing processes and rewarded with more flexibility in adaptation and optimization. This webinar will outline the importance of Quality by Design for Lyophilization and discuss conventional as well as novel approaches for the use of PAT tools in freeze drying operations. Several PAT methods will be briefly discussed, and special attention will be paid to MTM and SMART technology. |
