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Simulated Media Challenge and Environmental Qualification of an Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Jan. 27-28, 2000
 
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
 
Qualification and Regulatory Issues for a CBER Licensed Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Oct. 16-17, 2000
 
The regulatory process for the CBER licensing of an isolated filling line is discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter.
 
 

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