Change Control for FDA Regulated Industries: A Risk Assessment Approach - Couverture rigide

Muchemu, David N.

 
9781434314680: Change Control for FDA Regulated Industries: A Risk Assessment Approach
Couverture rigide
ISBN 10 : 1434314685 ISBN 13 : 9781434314680
Editeur : AuthorHouse, 2007

Synopsis

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

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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

Biographie de l'auteur

Mr Muchemu is the founder,and CEO of Quality Systems International,(QSi),LLC,a consulting firm for FDA regulated industries in the capital of the Silcon Valley,(San Jose,CA).He has over twenty five years expencience in cGMP companies.He has served in different capacities in the Quality Management arena at Boston Scientific,Johnson and Johson,Genentech,American Redcross Biomedical services,Applied Biosystems and Tissue Banks international.Mr Muchemu is an advocate of profitability through compliance,and continous process improvement.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
AuthorHouse
Date d'édition
2007
Langue
anglais
ISBN 10 
1434314685
ISBN 13 
9781434314680
Reliure
Relié
Nombre de pages
148
Coordonnées du fabricant
non disponible
Personne responsable
KreGa Onlinehandel GmbH
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info@krega-onlinehandel.de

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Autres éditions populaires du même titre

9781434314673: CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH

Edition présentée

ISBN 10 :  1434314677 ISBN 13 :  9781434314673
Editeur : AuthorHouse, 2007
Couverture souple