Application of a Risk-based Approach to Freeze-Drying Processes - Training / Workshop von PDA Europe gGmbH

One master piece of current process validation approach is risk analysis. It allows defining and measuring the critical parameters of the process for which a specific level of scrutiny is necessary in order to end-up with a robust process under control. The objective of this course is to give an understanding of risk management through ICHQ9 applied to the freeze-drying process.

Upon completion of this course, you will be able to:

• Better understand the Freeze-Drying process explained through the different examples
• Master ICH Q9 approach in term of risk-based approach
• Recognize a critical parameters for a process
• Score the criticality of a parameters
• Work in team by reaching consensus around criticality levels