Carte Change Control for Fda Regulated Industries David N Muchemu

Change Control for Fda Regulated Industries

A Risk Assesment Approach

Limbă: engleză
Legare: Copertă tare
Editura: AuthorHouse
Disponibilitate: În depozitul extern
Expediem în 14-21 zile
192.65 lei
This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device,...

Informații despre carte

Limbă
engleză
Legare
Carte - Copertă tare
Publicat
2007
Pagini
148
EAN
9781434314680
ISBN
9781434314680
Enbook ID
08493299
Editura
Greutate
398
Dimensiuni
161 x 237 x 18

Descriere completă

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 syst that meets and exceeds cGMP requirements

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