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Change Control for Fda Regulated Industries: a Risk Assesment Approach David N. Muchemu
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Change Control for Fda Regulated Industries: a Risk Assesment Approach
David N. Muchemu
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
| Media | Books Hardcover Book (Book with hard spine and cover) |
| Released | October 13, 2007 |
| ISBN13 | 9781434314680 |
| Publishers | AuthorHouse |
| Pages | 148 |
| Dimensions | 13 × 152 × 229 mm · 376 g |
| Language | English |
