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Author: Mustafa Edik
Publisher: CRC Press
ISBN: 1003814042
Category : Medical
Languages : en
Pages : 474
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Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Mustafa Edik
Publisher: CRC Press
ISBN: 1003814042
Category : Medical
Languages : en
Pages : 474
Get Book Here
Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Lance B. Coleman
Publisher: Quality Press
ISBN: 1951058119
Category : Business & Economics
Languages : en
Pages : 324
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Book Description
The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.
Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 393
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Book Description
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr
Author: Pharmaceutical Quality Group
Publisher:
ISBN: 9780906810682
Category : Drugs
Languages : en
Pages : 56
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Book Description
Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 453
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Book Description
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author: Food and Agriculture Organization of the United Nations
Publisher: Fao
ISBN:
Category : Business & Economics
Languages : en
Pages : 244
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Book Description
One important element of FAO's work is building the capacity of food control personnel, including government authorities and food industry personnel carrying out food quality and safety assurance programmes. Such programmes should include specific food risk control procedures such as the Hazard Analysis and Critical Control Point (HACCP) system. FAO has prepared this manual in an effort to harmonise the approach to training in the HACCP system based on the already harmonised texts and guidelines of the Codex Alimentarius Commission. The manual is structured to provide essential information in a standardised, logical and systematic manner while adhering to effective teaching and learning strategies. Each section is made up of specific training modules which can be combined and customised to meet the specific needs of the students. 1998 (first edition), 2009 (this reprint). Also published in French, Russian and Spanish.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Author: International Finance Corporation
Publisher: World Bank Publications
ISBN: 1464815496
Category : Technology & Engineering
Languages : en
Pages : 505
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Book Description
The Food Safety Handbook: A Practical Guide for Building a Robust Food Safety Management System, contains detailed information on food safety systems and what large and small food industry companies can do to establish, maintain, and enhance food safety in their operations. This new edition updates the guidelines and regulations since the previous 2016 edition, drawing on best practices and the knowledge IFC has gained in supporting food business operators around the world. The Food Safety Handbook is indispensable for all food business operators -- anywhere along the food production and processing value chain -- who want to develop a new food safety system or strengthen an existing one.
Author: Joseph S Turner
Publisher: Swenson Turner, Inc.
ISBN: 097798043X
Category :
Languages : en
Pages : 135
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Book Description
Study this book, use the techniques, tactics, tips and tricks you find inside, and you will get out of the job search game sooner, into the job you want -- in any economic market and on your own! Here's just some of what you'll find in this phenomenal book: -Closely-held secrets that deliver SUCCESS to headhunters -17 Bonus Tips -- little ideas and actions that magnify positive outcomes -The RIGHT WAY register at the online services like Monster -Proven ways to assure that your rsum will be read, not filed or tossed -How to make a strong impression in a phone interview -Strategies for assuring yourself an in-person interview -A dynamic action plan for that all-important face-to-face meeting -A very clever way to be THE ONLY PERSON applying for a specific job! -Mind-blowing ways to discover unadvertised jobs -The magic question to ask when you're rejected Employed now? Start immediately to plan for the next job change you will make -- yes, you WILL make a change; it's not a matter of whether, it's a matter of WHEN. Be prepared with this comprehensive, life-changing guidebook! Using the author's 15 years of hands-on experience with hundreds of candidates as your guide, you will uncover just the job you really want, and in the process you will lighten the burden of job hunting, you'll command the field of play in the contact, interview and critical salary/benefit negotiating stages of your transition -- and you'll do it with ease, confidently, and to your highest benefit!
