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Author: Mark Allen Durivage
Publisher:
Published: 2024-02-28
Total Pages: 0
ISBN-13: 9781636941493
DOWNLOAD EBOOKDownload or read book The Certified Pharmaceutical GMP Professional Handbook Third Edition written by Mark Allen Durivage and published by . This book was released on 2024-02-28 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2016-05-26
Total Pages: 516
ISBN-13: 0873899334
DOWNLOAD EBOOKThe 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 book The Certified Pharmaceutical GMP Professional Handbook, Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author: Mark Allen Durivage
Publisher:
Published: 2014
Total Pages: 0
ISBN-13: 9780873897945
DOWNLOAD EBOOKDownload or read book Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Heather Crawford
Publisher: Quality Press
Published: 2017-09-08
Total Pages: 300
ISBN-13: 0873899628
DOWNLOAD EBOOKThe Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Download or read book The Biomedical Quality Auditor Handbook, Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2017-07-07
Total Pages: 360
ISBN-13: 195105881X
DOWNLOAD EBOOKA comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.
Download or read book The Certified Reliability Engineer Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2017-07-07 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.
Author: Brendan Cooper
Publisher: Createspace Independent Publishing Platform
Published: 2017-07-17
Total Pages: 150
ISBN-13: 9781548370251
DOWNLOAD EBOOKCGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Download or read book The GMP Handbook written by Brendan Cooper and published by Createspace Independent Publishing Platform. This book was released on 2017-07-17 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2015-07-27
Total Pages: 170
ISBN-13: 0873899156
DOWNLOAD EBOOKThis 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 dont 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 book Practical Attribute and Variable Measurement Systems Analysis (MSA) written by Mark Allen Durivage and published by Quality Press. This book was released on 2015-07-27 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 dont 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).
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2016-02-25
Total Pages: 204
ISBN-13: 0873899245
DOWNLOAD EBOOKThis 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 book Practical Design of Experiments (DOE) written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-02-25 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
Author: Connie M. Borror
Publisher: Quality Press
Published: 2015-11-30
Total Pages: 360
ISBN-13: 1953079040
DOWNLOAD EBOOKThis book is primarily meant to aid those taking the ASQ Certified Quality Engineer (CQE) exam and is best used in conjunction with The Certified Quality Engineer Handbook. Section 1 provides 380 practice questions organized by the seven parts of the 2015 Body of Knowledge (BOK). Section 2 gives the reader 205 additional practice questions from each of the seven parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BOK the question corresponds to so that any further study needed can be focused on specific sections. A secondary audience is those taking exams for ASQ certifications whose BOKs’ have some crossover with the CQE. Namely, the Certified Six Sigma Black Belt (CSSBB), Certified Six Sigma Green Belt (CSSGB), Certified Reliability Engineer (CRE), and Certified Quality Inspector (CQI). Using this guide in studying for any of these exams would be extremely useful, particularly for the statistics portions of the BOKs. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2015 CQE Body of Knowledge and help those studying for it, including taking into account the proper depth of knowledge and required levels of cognition. None of this material has appeared in any previous resource or been shoehorned into fitting under the BOK’s topics. NOTE: Practice/sample test questions such as those in this study guide cannot be taken into ASQ certification exam rooms.
Download or read book The ASQ CQE Study Guide written by Connie M. Borror and published by Quality Press. This book was released on 2015-11-30 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is primarily meant to aid those taking the ASQ Certified Quality Engineer (CQE) exam and is best used in conjunction with The Certified Quality Engineer Handbook. Section 1 provides 380 practice questions organized by the seven parts of the 2015 Body of Knowledge (BOK). Section 2 gives the reader 205 additional practice questions from each of the seven parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BOK the question corresponds to so that any further study needed can be focused on specific sections. A secondary audience is those taking exams for ASQ certifications whose BOKs’ have some crossover with the CQE. Namely, the Certified Six Sigma Black Belt (CSSBB), Certified Six Sigma Green Belt (CSSGB), Certified Reliability Engineer (CRE), and Certified Quality Inspector (CQI). Using this guide in studying for any of these exams would be extremely useful, particularly for the statistics portions of the BOKs. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2015 CQE Body of Knowledge and help those studying for it, including taking into account the proper depth of knowledge and required levels of cognition. None of this material has appeared in any previous resource or been shoehorned into fitting under the BOK’s topics. NOTE: Practice/sample test questions such as those in this study guide cannot be taken into ASQ certification exam rooms.
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2014-10-27
Total Pages: 278
ISBN-13: 0873898893
DOWNLOAD EBOOKThis 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 book Practical Engineering, Process, and Reliability Statistics written by Mark Allen Durivage and published by Quality Press. This book was released on 2014-10-27 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
