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The Certified Pharmaceutical Gmp Professional Handbook Second Edition

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The Certified Pharmaceutical GMP Professional Handbook, Second Edition

The Certified Pharmaceutical GMP Professional Handbook, Second Edition [Pdf/ePub] eBook Author: ,
Editor: Quality Press
ISBN-10: 0873899334
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The Certified Pharmaceutical GMP Professional Handbook, Second Edition by , Book Summary:

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Download or read The Certified Pharmaceutical GMP Professional Handbook, Second Edition book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc).


Practical Process Validation

Practical Process Validation [Pdf/ePub] eBook Author: Mark Allen Durivage,Bob (Bhavan) Mehta
Editor: Quality Press
ISBN-10: 0873899369
Size: 1546 kb
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Practical Process Validation by Mark Allen Durivage,Bob (Bhavan) Mehta Book Summary:

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Download or read Practical Process Validation book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.


Statistical Process Control for the FDA-Regulated Industry

Statistical Process Control for the FDA-Regulated Industry [Pdf/ePub] eBook Author: Manuel E. Pena-Rodriguez
Editor: Quality Press
ISBN-10: 0873898524
Size: 1975 kb
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Statistical Process Control for the FDA-Regulated Industry by Manuel E. Pena-Rodriguez Book Summary:

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.

Download or read Statistical Process Control for the FDA-Regulated Industry book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). 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.


Quality Risk Management in the FDA-Regulated Industry

Quality Risk Management in the FDA-Regulated Industry [Pdf/ePub] eBook Author: José Rodríguez Pérez
Editor: Quality Press
ISBN-10: 0873898346
Size: 761 kb
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Quality Risk Management in the FDA-Regulated Industry by José Rodríguez Pérez Book Summary:

Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that “absolute safety” (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.

Download or read Quality Risk Management in the FDA-Regulated Industry book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that “absolute safety” (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.


Human Error Reduction in Manufacturing

Human Error Reduction in Manufacturing [Pdf/ePub] eBook Author: José Rodríguez-Pérez
Editor: Quality Press
ISBN-10: 0873899733
Size: 891 kb
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Human Error Reduction in Manufacturing by José Rodríguez-Pérez Book Summary:

For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple “industry” language with abundant applied examples and practical references, this book’s insights on human failure reduction will improve individual, organizational, and social well-being.

Download or read Human Error Reduction in Manufacturing book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple “industry” language with abundant applied examples and practical references, this book’s insights on human failure reduction will improve individual, organizational, and social well-being.


The Lean Six Sigma Black Belt Handbook

The Lean Six Sigma Black Belt Handbook [Pdf/ePub] eBook Author: Frank Voehl,H. James Harrington,Chuck Mignosa,Rich Charron
Editor: CRC Press
ISBN-10: 146655469X
Size: 1097 kb
Format File: Pdf
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The Lean Six Sigma Black Belt Handbook by Frank Voehl,H. James Harrington,Chuck Mignosa,Rich Charron Book Summary:

Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these seemingly dissimilar approaches to increase production speed while decreas

Download or read The Lean Six Sigma Black Belt Handbook book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these seemingly dissimilar approaches to increase production speed while decreas


Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry [Pdf/ePub] eBook Author: Steven Ostrove
Editor: Academic Press
ISBN-10: 0128175699
Size: 446 kb
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Equipment Qualification in the Pharmaceutical Industry by Steven Ostrove Book Summary:

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Download or read Equipment Qualification in the Pharmaceutical Industry book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements


Handbook of Investigation and Effective CAPA Systems, Second Edition

Handbook of Investigation and Effective CAPA Systems, Second Edition [Pdf/ePub] eBook Author: José Rodríguez-Pérez
Editor: Quality Press
ISBN-10: 0873899261
Size: 1033 kb
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Handbook of Investigation and Effective CAPA Systems, Second Edition by José Rodríguez-Pérez Book Summary:

Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

Download or read Handbook of Investigation and Effective CAPA Systems, Second Edition book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.


Practical Engineering, Process, and Reliability Statistics

Practical Engineering, Process, and Reliability Statistics [Pdf/ePub] eBook Author: Mark Allen Durivage
Editor: Quality Press
ISBN-10: 0873898893
Size: 1643 kb
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Practical Engineering, Process, and Reliability Statistics by Mark Allen Durivage Book Summary:

This book was written to aid quality technicians and engineers. It is a compilation of 30 years of quality-related work experience and the result of frustration at the number of books necessary, at times, to provide statistical support. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly utilize statistics in an efficient and effective manner. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE). This book is an expansion of the work of Robert A. Dovich in his books Quality Engineering Statistics and Reliability Statistics. It builds on and expands Dovich's method of presenting statistical applications in a simple, easy-to-follow format.

Download or read Practical Engineering, Process, and Reliability Statistics book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). This book was written to aid quality technicians and engineers. It is a compilation of 30 years of quality-related work experience and the result of frustration at the number of books necessary, at times, to provide statistical support. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly utilize statistics in an efficient and effective manner. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE). This book is an expansion of the work of Robert A. Dovich in his books Quality Engineering Statistics and Reliability Statistics. It builds on and expands Dovich's method of presenting statistical applications in a simple, easy-to-follow format.


Practical Design of Experiments (DOE)

Practical Design of Experiments (DOE) [Pdf/ePub] eBook Author: Mark Allen Durivage
Editor: Quality Press
ISBN-10: 0873899245
Size: 883 kb
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Practical Design of Experiments (DOE) by Mark Allen Durivage Book Summary:

This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization. This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts. In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).

Download or read Practical Design of Experiments (DOE) book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization. This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts. In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).


The ASQ CSSBB Study Guide

The ASQ CSSBB Study Guide [Pdf/ePub] eBook Author: Mark Allen Durivage,Shawn Findlater
Editor: Quality Press
ISBN-10: 1951058593
Size: 1806 kb
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The ASQ CSSBB Study Guide by Mark Allen Durivage,Shawn Findlater Book Summary:

Practice questions and test to aid those studying to take the ASQ Certified Six Sigma Black Belt exam. Practice questions and a practice exam to aid those studying to take the ASQ Certified Six Sigma Black Belt exam.

Download or read The ASQ CSSBB Study Guide book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Practice questions and test to aid those studying to take the ASQ Certified Six Sigma Black Belt exam. Practice questions and a practice exam to aid those studying to take the ASQ Certified Six Sigma Black Belt exam.


Essential Management Skills for Pharmacy and Business Managers

Essential Management Skills for Pharmacy and Business Managers [Pdf/ePub] eBook Author: Titus De Silva
Editor: CRC Press
ISBN-10: 1482218828
Size: 1633 kb
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Essential Management Skills for Pharmacy and Business Managers by Titus De Silva Book Summary:

As a manager you will be expected to resolve a range of legal, ethical, operational, human resource, and financial issues that affect your organization. Essential Management Skills for Pharmacy and Business Managers supplies the understanding you will need to manage the day-to-day challenges in this increasingly competitive environment. Presenting a wealth of information on how to resolve common issues across all sectors of the pharmacy environment, it uses case studies to illustrate the methods required to create a patient-focused business where teamwork flourishes and continuous improvement becomes a reality. The book describes the kinds of things that will most often go wrong in organizations of all types and sizes and provides proven methods for resolving these issues. It explains how to develop and implement an effective quality management system in the pharmacy or a retail operation that complies with external standards. Outlining an efficient performance appraisal system, it describes how to manage diversity and details time-tested problem solving, conflict management, and stress management techniques. With coverage that includes employee management, quality management, and quality assurance, the book describes how to create a harmonious work environment that promotes effective communication between pharmacy staff, medical professionals, care givers, patients, and customers. Complete with links to further information in each chapter, it arms you with the tools to empower and motivate your employees to provide world-class patient and customer care.

Download or read Essential Management Skills for Pharmacy and Business Managers book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). As a manager you will be expected to resolve a range of legal, ethical, operational, human resource, and financial issues that affect your organization. Essential Management Skills for Pharmacy and Business Managers supplies the understanding you will need to manage the day-to-day challenges in this increasingly competitive environment. Presenting a wealth of information on how to resolve common issues across all sectors of the pharmacy environment, it uses case studies to illustrate the methods required to create a patient-focused business where teamwork flourishes and continuous improvement becomes a reality. The book describes the kinds of things that will most often go wrong in organizations of all types and sizes and provides proven methods for resolving these issues. It explains how to develop and implement an effective quality management system in the pharmacy or a retail operation that complies with external standards. Outlining an efficient performance appraisal system, it describes how to manage diversity and details time-tested problem solving, conflict management, and stress management techniques. With coverage that includes employee management, quality management, and quality assurance, the book describes how to create a harmonious work environment that promotes effective communication between pharmacy staff, medical professionals, care givers, patients, and customers. Complete with links to further information in each chapter, it arms you with the tools to empower and motivate your employees to provide world-class patient and customer care.


How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process [Pdf/ePub] eBook Author: Steven Ostrove
Editor: Academic Press
ISBN-10: 0128096535
Size: 1529 kb
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How to Validate a Pharmaceutical Process by Steven Ostrove Book Summary:

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Download or read How to Validate a Pharmaceutical Process book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more


Handbook of Hydrocolloids

Handbook of Hydrocolloids [Pdf/ePub] eBook Author: Glyn O. Phillips,P A Williams
Editor: Elsevier
ISBN-10: 1845695879
Size: 1857 kb
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Handbook of Hydrocolloids by Glyn O. Phillips,P A Williams Book Summary:

Hydrocolloids are among the most widely used ingredients in the food industry. They function as thickening and gelling agents, texturizers, stabilisers and emulsifiers and in addition have application in areas such as edible coatings and flavour release. Products reformulated for fat reduction are particularly dependent on hydrocolloids for satisfactory sensory quality. They now also find increasing applications in the health area as dietary fibre of low calorific value. The first edition of Handbook of Hydrocolloids provided professionals in the food industry with relevant practical information about the range of hydrocolloid ingredients readily and at the same time authoritatively. It was exceptionally well received and has subsequently been used as the substantive reference on these food ingredients. Extensively revised and expanded and containing eight new chapters, this major new edition strengthens that reputation. Edited by two leading international authorities in the field, the second edition reviews over twenty-five hydrocolloids, covering structure and properties, processing, functionality, applications and regulatory status. Since there is now greater emphasis on the protein hydrocolloids, new chapters on vegetable proteins and egg protein have been added. Coverage of microbial polysaccharides has also been increased and the developing role of the exudate gums recognised, with a new chapter on Gum Ghatti. Protein-polysaccharide complexes are finding increased application in food products and a new chapter on this topic as been added. Two additional chapters reviewing the role of hydrocolloids in emulsification and their role as dietary fibre and subsequent health benefits are also included. The second edition of Handbook of hydrocolloids is an essential reference for post-graduate students, research scientists and food manufacturers. Extensively revised and expanded second edition edited by two leading international authorities Provides an introduction to food hydrocolliods considering regulatory aspects and thickening characteristics Comprehensively examines the manufacture, structure, function and applications of over twenty five hydrocolloids

Download or read Handbook of Hydrocolloids book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Hydrocolloids are among the most widely used ingredients in the food industry. They function as thickening and gelling agents, texturizers, stabilisers and emulsifiers and in addition have application in areas such as edible coatings and flavour release. Products reformulated for fat reduction are particularly dependent on hydrocolloids for satisfactory sensory quality. They now also find increasing applications in the health area as dietary fibre of low calorific value. The first edition of Handbook of Hydrocolloids provided professionals in the food industry with relevant practical information about the range of hydrocolloid ingredients readily and at the same time authoritatively. It was exceptionally well received and has subsequently been used as the substantive reference on these food ingredients. Extensively revised and expanded and containing eight new chapters, this major new edition strengthens that reputation. Edited by two leading international authorities in the field, the second edition reviews over twenty-five hydrocolloids, covering structure and properties, processing, functionality, applications and regulatory status. Since there is now greater emphasis on the protein hydrocolloids, new chapters on vegetable proteins and egg protein have been added. Coverage of microbial polysaccharides has also been increased and the developing role of the exudate gums recognised, with a new chapter on Gum Ghatti. Protein-polysaccharide complexes are finding increased application in food products and a new chapter on this topic as been added. Two additional chapters reviewing the role of hydrocolloids in emulsification and their role as dietary fibre and subsequent health benefits are also included. The second edition of Handbook of hydrocolloids is an essential reference for post-graduate students, research scientists and food manufacturers. Extensively revised and expanded second edition edited by two leading international authorities Provides an introduction to food hydrocolliods considering regulatory aspects and thickening characteristics Comprehensively examines the manufacture, structure, function and applications of over twenty five hydrocolloids


Nutraceutical and Functional Food Regulations in the United States and Around the World

Nutraceutical and Functional Food Regulations in the United States and Around the World [Pdf/ePub] eBook Author: Debasis Bagchi
Editor: Elsevier
ISBN-10: 0124059120
Size: 574 kb
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Nutraceutical and Functional Food Regulations in the United States and Around the World by Debasis Bagchi Book Summary:

This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world. Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators Offers 45% new content including three new chapters –NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements Includes insight into working with regulatory agencies, processes and procedures Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge

Download or read Nutraceutical and Functional Food Regulations in the United States and Around the World book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world. Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators Offers 45% new content including three new chapters –NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements Includes insight into working with regulatory agencies, processes and procedures Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge


The Certified Reliability Engineer Handbook

The Certified Reliability Engineer Handbook [Pdf/ePub] eBook Author: Mark Allen Durivage
Editor: Quality Press
ISBN-10: 195105881X
Size: 1412 kb
Format File: Pdf
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The Certified Reliability Engineer Handbook by Mark Allen Durivage Book Summary:

A comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.

Download or read The Certified Reliability Engineer Handbook book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). A comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.


Managing Organizational Risk Using the Supplier Audit Program

Managing Organizational Risk Using the Supplier Audit Program [Pdf/ePub] eBook Author: Lance B. Coleman, Sr
Editor: Quality Press
ISBN-10: 0873899687
Size: 442 kb
Format File: Pdf
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Managing Organizational Risk Using the Supplier Audit Program by Lance B. Coleman, Sr Book Summary:

Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organization’s walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well. The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQ’s Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The author’s friends and colleagues from around the globe shared their own stories in “Case in Point” vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.

Download or read Managing Organizational Risk Using the Supplier Audit Program book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organization’s walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well. The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQ’s Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The author’s friends and colleagues from around the globe shared their own stories in “Case in Point” vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.


Human Error Reduction in Manufacturing

Human Error Reduction in Manufacturing [Pdf/ePub] eBook Author: José Rodríguez-Pérez
Editor: Quality Press
ISBN-10: 0873899733
Size: 1707 kb
Format File: Pdf
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Human Error Reduction in Manufacturing by José Rodríguez-Pérez Book Summary:

For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple “industry” language with abundant applied examples and practical references, this book’s insights on human failure reduction will improve individual, organizational, and social well-being.

Download or read Human Error Reduction in Manufacturing book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple “industry” language with abundant applied examples and practical references, this book’s insights on human failure reduction will improve individual, organizational, and social well-being.


Practical Process Validation

Practical Process Validation [Pdf/ePub] eBook Author: Mark Allen Durivage,Bob (Bhavan) Mehta
Editor: Quality Press
ISBN-10: 0873899369
Size: 1141 kb
Format File: Pdf
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Practical Process Validation by Mark Allen Durivage,Bob (Bhavan) Mehta Book Summary:

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Download or read Practical Process Validation book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.


Practical Attribute and Variable Measurement Systems Analysis (MSA)

Practical Attribute and Variable Measurement Systems Analysis (MSA) [Pdf/ePub] eBook Author: Mark Allen Durivage
Editor: Quality Press
ISBN-10: 0873899156
Size: 581 kb
Format File: Pdf
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Practical Attribute and Variable Measurement Systems Analysis (MSA) by Mark Allen Durivage Book Summary:

This book — a result of 30 years of quality-related work experience — was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA). The intent of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that don’t fit the usual approach, and ideas for measurement devices that require innovation to assess their performance under off-line, static conditions. The ultimate objective is to determine how best to improve the control and performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important. One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharmaceutical, and medical device industries. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).

Download or read Practical Attribute and Variable Measurement Systems Analysis (MSA) book by clicking button below to visit the book download website. There are multiple format available for you to choose (Pdf, ePub, Doc). This book — a result of 30 years of quality-related work experience — was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA). The intent of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that don’t fit the usual approach, and ideas for measurement devices that require innovation to assess their performance under off-line, static conditions. The ultimate objective is to determine how best to improve the control and performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important. One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharmaceutical, and medical device industries. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).