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Change Control for Fda Regulated Industries
David N. Muchemu
其他書名
A Risk Assesment Approach
出版AuthorHouse, 2007
主題Business & Economics / Accounting / ManagerialBusiness & Economics / Careers / GeneralBusiness & Economics / ManagementBusiness & Economics / Production & Operations ManagementSelf-Help / GeneralSelf-Help / Personal Growth / SuccessTechnology & Engineering / Pharmaceutical
ISBN14343146859781434314680
URLhttp://books.google.com.hk/books?id=0Vm7yfj8_jUC&hl=&source=gbs_api
EBookSAMPLE
註釋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