Process Validation and ICH Q7

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FDA discusses manufacturing validation data from an FDA review perspective.
Presenter:
David Amspacher, Division of Lifecycle API

-------------------- 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
Phone - (301) 796-6707 I (866) 405-5367
  1. U.S. Food and Drug Administration
  2. FDA
  3. CDER
  4. SBIA
  5. DMF
  6. DrugMasterFiles
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