Instructor Led Process Validation Training
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From Global BioPharmaceutical Resources, Inc. (GBPR, Inc.)
THE NEW PROCESS VALIDATION GUIDANCE AND ITS APPLICATION TO PHASE 1 THRU PHASE 3 DEVELOPMENT OF cGMP
This seminar will debunk the myths that one must follow all 210/ 211 requirements in a Phase 1 environment; however, it will discuss those elements that remain required and where Stages 1 and 2 complement this "puzzle".
The objective of this one day interactive seminar is to explore the "New" FDA Process Validation Guidelines as well as the manufacture of Phase 1 Investigational New Drugs,
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