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About The Book
Description
Author
This Book Accomplishes The Following: .It Addresses Requirements For Pharmaceutical Medical Device Biologics And Tissue Banking Change Control .Defines The Different Phases Of The Change Control Life Cycle .Establishes The Relationship Between Risk Management Cost Of Doing Business And Change Control .Defines Regulatory Requirements For Change Control Including Requirements For (510K) Submission .Provides Tools For Risk Assesment And Cost/Benefit Analysis .Helps The Reader Design A Change Control System That Meets And Exceeds Cgmp Requirements
Piracy-free
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Details
ISBN 13
9781434314680
Publication Date
-13-10-2007
Pages
-148
Weight
-298 grams
Dimensions
-152x229x12.7 mm
