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

Inhalte

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.

Lernziele

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

Zielgruppen

Any professionals with interest in Freeze Drying.

SG-Seminar-Nr.: 1785787

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