Statistical Process Control for the FDA-Regulated Industry

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Title: Statistical Process Control for the FDA-Regulated Industry
Description: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author's almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
Authors: Manuel E. Pena-Rodriguez
Resource Type: eBook.
Subjects: Process control--Statistical methods, Manufacturing processes--Quality control.--Uni
Categories: TECHNOLOGY & ENGINEERING / Quality Control, BUSINESS & ECONOMICS / Quality Control, BUSINESS & ECONOMICS / Statistics
Database: eBook Collection (EBSCOhost)
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DbLabel: eBook Collection (EBSCOhost)
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PubType: eBook
PubTypeId: ebook
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  Data: Statistical Process Control for the FDA-Regulated Industry
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  Data: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author's almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
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RecordInfo BibRecord:
  BibEntity:
    Classifications:
      – Code: 658.50727
        Scheme: ddc
        Type: prePub
    Languages:
      – Code: eng
        Text: English
    Subjects:
      – SubjectFull: Process control--Statistical methods
        Type: general
      – SubjectFull: Manufacturing processes--Quality control.--Uni
        Type: general
    Titles:
      – TitleFull: Statistical Process Control for the FDA-Regulated Industry
        Type: main
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      – PersonEntity:
          Name:
            NameFull: Manuel E. Pena-Rodriguez
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          Name:
            NameFull: Manuel E. Pena-Rodriguez
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          Dates:
            – D: 01
              M: 01
              Type: published
              Y: 2013
            – D: 08
              M: 07
              Type: profile
              Y: 2014
          Identifiers:
            – Type: isbn-print
              Value: 9780873898522
            – Type: isbn-electronic
              Value: 9781953079794
            – Type: isbn-electronic
              Value: 9781953079800
          Titles:
            – TitleFull: Statistical Process Control for the FDA-Regulated Industry
              Type: main
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