Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Pharmaceutical Engineering Change Control
Download Pharmaceutical Engineering Change Control full books in PDF, epub, and Kindle. Read online Pharmaceutical Engineering Change Control ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Pharmaceutical Engineering Change Control by : Simon G. Turner
Download or read book Pharmaceutical Engineering Change Control written by Simon G. Turner and published by CRC Press. This book was released on 2019-08-30 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.
Book Synopsis Practical Pharmaceutical Engineering by : Gary Prager
Download or read book Practical Pharmaceutical Engineering written by Gary Prager and published by John Wiley & Sons. This book was released on 2018-11-28 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
Book Synopsis Change Control for FDA Regulated Industries by : David N. Muchemu
Download or read book Change Control for FDA Regulated Industries written by David N. Muchemu and published by AuthorHouse. This book was released on 2007 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements
Book Synopsis Quality (Pharmaceutical Engineering Series) by : Kate McCormick
Download or read book Quality (Pharmaceutical Engineering Series) written by Kate McCormick and published by Butterworth-Heinemann. This book was released on 2002-09-24 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working
Book Synopsis Pharmaceutical Manufacturing Change Control by : Simon G. Turner
Download or read book Pharmaceutical Manufacturing Change Control written by Simon G. Turner and published by CRC Press. This book was released on 1999-01-31 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Change control is important for maintaining the quality of the product, the safety of product and operation, the protection of the environment, and the profitability of the company. Beginning with basic preparatory information, this book covers all aspects of change control: planning, checking, procedures, and key aspects of quality control throughout the entire change control process. It emphasizes the management of change control and gives readers guidance on its various aspects. Numerous case studies and anecdotes illustrate key points and are useful in change control training. They also serve as models for readers to use in developing their own case study library.
Book Synopsis Technology Development and Marketing by : Junmo Kim
Download or read book Technology Development and Marketing written by Junmo Kim and published by AuthorHouse. This book was released on 2018-06-07 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology development needs a market. Since technology development is from supply side, it is always crucial to pay attention to the demand side of technology. Taking this notion as an underlying assumption, this book discusses a technology development case in the realm of microelectronic packaging technology based on a real case study of a three-year consecutive research and development program conducted in Korea with expandable implications for other contexts.
Book Synopsis Pharmaceutical Production by : Bill Bennett
Download or read book Pharmaceutical Production written by Bill Bennett and published by IChemE. This book was released on 2003 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.
Book Synopsis Good Design Practices for GMP Pharmaceutical Facilities by : Terry Jacobs
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Book Synopsis Modern Aspects of Pharmaceutical Quality Assurance by : Minal Ghante
Download or read book Modern Aspects of Pharmaceutical Quality Assurance written by Minal Ghante and published by Springer Nature. This book was released on with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Validation of Pharmaceutical Processes by : James P. Agalloco
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah
Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-02-01 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Book Synopsis What Went Wrong? Pharma Tech Case Studies by : P G Shrotriya
Download or read book What Went Wrong? Pharma Tech Case Studies written by P G Shrotriya and published by Notion Press. This book was released on 2020-06-21 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of What Went Wrong? Pharma Tech Case Studies is to provide multidisciplinary approaches/guidelines for problem-solving capability. These case studies are based on the actual situation faced by the author in India and overseas and successfully resolved with the back-up of science and technology convincing international regulators/complainants leading to the closing of complaints. The book provides guidelines covering regulatory requirements for documentation. How do you document (format) any complaint? How to investigate a case study, using knowledge of science and technology and method of investigation? How to reproduce the complaint in-house, where ever required? It answers these various questions. The conclusion is with corrective and preventive actions required, submission of the investigation report and assignable reason to the regulatory agency/complainant, getting a response from the complainant and once satisfied, requesting them to close the complaint. Can we integrate regulatory science with other subjects of pharmaceutical sciences to learn ‘What Went Wrong? In Pharma Tech Case Study’. Important regulatory references are provided at the end.
Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Book Synopsis Pharmaceutical Blending and Mixing by : P. J. Cullen
Download or read book Pharmaceutical Blending and Mixing written by P. J. Cullen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.
Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-03-19 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Book Synopsis Introduction to Chemical Engineering by : Uche P. Nnaji
Download or read book Introduction to Chemical Engineering written by Uche P. Nnaji and published by John Wiley & Sons. This book was released on 2019-09-30 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of chemical engineering is undergoing a global “renaissance,” with new processes, equipment, and sources changing literally every day. It is a dynamic, important area of study and the basis for some of the most lucrative and integral fields of science. Introduction to Chemical Engineering offers a comprehensive overview of the concept, principles and applications of chemical engineering. It explains the distinct chemical engineering knowledge which gave rise to a general-purpose technology and broadest engineering field. The book serves as a conduit between college education and the real-world chemical engineering practice. It answers many questions students and young engineers often ask which include: How is what I studied in the classroom being applied in the industrial setting? What steps do I need to take to become a professional chemical engineer? What are the career diversities in chemical engineering and the engineering knowledge required? How is chemical engineering design done in real-world? What are the chemical engineering computer tools and their applications? What are the prospects, present and future challenges of chemical engineering? And so on. It also provides the information new chemical engineering hires would need to excel and cross the critical novice engineer stage of their career. It is expected that this book will enhance students understanding and performance in the field and the development of the profession worldwide. Whether a new-hire engineer or a veteran in the field, this is a must—have volume for any chemical engineer’s library.
Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture