Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage

Learning Objectives:

● Explain the importance of tracking time-out-of-environment for cold chain investigational products.
● Describe at least two (2) types of stability studies that support investigational product time-out-of-environment.
● List at least two (2) challenges to tracking time-out-of environment for cold chain products.

 

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