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Change Control for FDA Regulated Industries

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Change Control for FDA Regulated Industries

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Description
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
Product details
Binding:
Paperback
Edition:
1
Number of Pages:
148
Release Date:
2007-10-15
Publication Date:
2007-10-13
Publisher:
AuthorHouse
Languages:
Original: English
ISBN10:
1434314677
ISBN13:
9781434314673
Weight:
226 g
Height:
152 cm
Width:
229 cm
Thickness:
9 cm

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Very good
Almost no signs of wear. Book pages have no markings, accessories are intact and all other media are in good condition.
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