Online Live Training
17 - 18 November | 13:00 CET – 18:00 CET
Course Overview:
Lyophilization (freeze drying) is used to improve pharmaceutical product stability through controlled removal of water or other solvents. This course examines the process-design stage of lyophilization validation, emphasizing scientific process understanding and the relationship among product, process, and equipment. Topics include freezing, primary and secondary drying; heat and mass transfer; vial heat-transfer coefficient (Kv); product resistance (Rp); design-space construction; equipment capability; engineering runs; mathematical modeling; scale-up and technology transfer; and controlled ice nucleation (CIN).
The course is based exclusively on the uploaded Part I guide and preserves its emphasis on industrial perspective, first-principles understanding, modeling, and CMC considerations.
Why Should You Attend?
If you are a professional who is involved in the development of pharmaceutical and biopharmaceutical products and processes using lyophilization, development of lyophilization processes, qualification of the lyophilization cycles, performance of lyophilization pharmaceutical processes throughout the continued lifecycle this course is definitely for you.
During this 2-part session we will discuss the development of lyophilization cycles, advanced design and development of pharmaceutical lyophilization processes, discuss development of lyophilization qualification programs, as well as discuss Annex 1 requirements for lyophilization.
Who will be benefited?
This Training is targeted towards the following organizational positions and disciplines. The trainer will present the material in a pragmatic and practical manner. This course would be useful at levels from senior management to those involved in product development, manufacturing and testing. It would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles process validation:
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