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Author : Christine Oechslein
Publisher :
ISBN 13 : 9783958071056
Total Pages : pages
Book Rating : 4.0/5 (71 download)
Download or read book GMP Fundamentals written by Christine Oechslein and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Rebecca Sheets
Publisher : Academic Press
ISBN 13 : 0128094435
Total Pages : 450 pages
Book Rating : 4.1/5 (28 download)
Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-13 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Author : Mustafa Edik
Publisher : CRC Press
ISBN 13 : 1003814042
Total Pages : 474 pages
Book Rating : 4.0/5 (38 download)
Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : JAMES. VESPER
Publisher :
ISBN 13 : 9781942911289
Total Pages : pages
Book Rating : 4.9/5 (112 download)
Download or read book GMP IN PRACTICE written by JAMES. VESPER and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Leszek Demkowicz
Publisher : CRC Press
ISBN 13 : 1420011693
Total Pages : 437 pages
Book Rating : 4.4/5 (2 download)
Download or read book Computing with hp-ADAPTIVE FINITE ELEMENTS written by Leszek Demkowicz and published by CRC Press. This book was released on 2007-11-02 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a focus on 1D and 2D problems, the first volume of Computing with hp-ADAPTIVE FINITE ELEMENTS prepared readers for the concepts and logic governing 3D code and implementation. Taking the next step in hp technology, Volume II Frontiers: Three-Dimensional Elliptic and Maxwell Problems with Applications presents the theoretical foundations of the
Author : Michael Cutter
Publisher : Interpharm Press
ISBN 13 : 9780935184990
Total Pages : 150 pages
Book Rating : 4.1/5 (849 download)
Download or read book How to Review and Redesign Sop Systems written by Michael Cutter and published by Interpharm Press. This book was released on 1995-06-01 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Terry Jacobs
Publisher : CRC Press
ISBN 13 : 1482258919
Total Pages : 535 pages
Book Rating : 4.4/5 (822 download)
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.
Author : David J. Lynn
Publisher : John Wiley and Sons
ISBN 13 : 0470522070
Total Pages : 400 pages
Book Rating : 4.4/5 (75 download)
Download or read book Active Private Equity Real Estate Strategy written by David J. Lynn and published by John Wiley and Sons. This book was released on 2009-07-30 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proven private equity real estate investing strategies The subprime fallout and credit crisis have triggered a major transition in U.S. real estate. With tightening lending and underwriting standards, speculative investments and construction projects are likely to limited, resulting in constrained supply and healthier fundamentals over the long term. Looking forward, market participants anticipate that the coming years will be fraught with challenges as well as opportunities. Active Private Equity Real Estate Strategy is a collection of abridged market analyses, forecasts, and strategy papers from the ING Clarion Partners' Research & Investment Strategy (RIS) group. Divided into two comprehensive parts, this practical guide provides you with an informative overview of real estate markets, forecasts, and recent trends in part one, and presents specific active strategies in private equity real estate investing in part two. Includes a simulation of the economy in recession and the expected effects on the commercial real estate industry Offers examples of portfolio analysis and recommendations using ING Clarion's forecasts and Modern Portfolio Theory Focuses on multifamily, hotel, land, and industrial investments Demonstrates the use of the various tools available to the private equity real estate investor Written with both the individual and institutional real estate investor in mind, this book offers specific private equity strategies for investing in real estate during volatile times.
Author : Eva D Quinley
Publisher : Jones & Bartlett Learning
ISBN 13 : 1284268799
Total Pages : 1009 pages
Book Rating : 4.2/5 (842 download)
Download or read book Immunohematology: Principles and Practice written by Eva D Quinley and published by Jones & Bartlett Learning. This book was released on 2020-06-15 with total page 1009 pages. Available in PDF, EPUB and Kindle. Book excerpt: Immunohematology: Principles and Practice, Third Edition an ideal text for anyone who wants to master the theory and practices of today's blood banking.
Author : Averil Burton Chatfield
Publisher : AIAA
ISBN 13 : 9781600864278
Total Pages : 368 pages
Book Rating : 4.8/5 (642 download)
Download or read book Fundamentals of High Accuracy Inertial Navigation written by Averil Burton Chatfield and published by AIAA. This book was released on 1997 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Robert H. Weichbrod
Publisher : CRC Press
ISBN 13 : 1351648225
Total Pages : 1405 pages
Book Rating : 4.3/5 (516 download)
Download or read book Management of Animal Care and Use Programs in Research, Education, and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 1405 pages. Available in PDF, EPUB and Kindle. Book excerpt: AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).
Author : Jeffrey S. Barrett
Publisher : John Wiley & Sons
ISBN 13 : 1119691699
Total Pages : 516 pages
Book Rating : 4.1/5 (196 download)
Download or read book Fundamentals of Drug Development written by Jeffrey S. Barrett and published by John Wiley & Sons. This book was released on 2022-09-07 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of DRUG DEVELOPMENT Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include: Drug development and its phases Decision-making processes, drug development milestones, and compound progression metrics The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development Differences in the nature and scope of development programs due to the therapeutic area of interest Associated costs and resources required Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.
Author : National Library of Medicine (U.S.)
Publisher :
ISBN 13 :
Total Pages : 1340 pages
Book Rating : 4.3/5 (91 download)
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1980 with total page 1340 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Author : P. Michael Dubinsky
Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Author : J Alex Ficarra
Publisher : AuthorHouse
ISBN 13 : 1491816368
Total Pages : 805 pages
Book Rating : 4.4/5 (918 download)
Download or read book Inspiring the Youth of America by Remington Registry written by J Alex Ficarra and published by AuthorHouse. This book was released on 2013-09-24 with total page 805 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here at Remington it has become clearly evident that mediocrity wasnot a path chosen by anyone in this book. It has also become vividly apparent that humanitarian contribution was a common theme in the lives of many of these professionals and as a company we made it our primary objective to recognize those contributions first and foremost. Although the foundation of our company is based on networking and mutual collaboration we felt it was our moral obligation to assist in any way we can the professionals who demonstrated extreme self-sacrifice and compassion for others. We would also like to mention that our staff went to great personal length to get the fine details of each and every person in this book. We pride ourselves in offering much more than a registry and a basic summary of each professional. We encourage you the reader to immerse yourself in the lives of others. Experience the joy, pain, adversity, fear and heroism of some of the most brilliant professionals on our planet. Speaking for myself and the staff of the Remington Registry of Outstanding Professionals we hope you enjoy reading our book and it is our sincere desire that you draw inspiration from it and use it as a tool when relentlessly pursuing your dreams.
Author : J Alex Ficarra
Publisher : Author House
ISBN 13 : 1477263780
Total Pages : 839 pages
Book Rating : 4.4/5 (772 download)
Download or read book The Remington Registry of Outstanding Professionals 2011-2012 written by J Alex Ficarra and published by Author House. This book was released on 2012-09-11 with total page 839 pages. Available in PDF, EPUB and Kindle. Book excerpt: Undoubtedly growing up during the Vietnam War, water gate and gas shortages can have a profound effect on a child. Also being the son of immigrant parents most certainly can lead to a traumatizing clash of cultures and the understanding of right and wrong. With that being said the Remington Company gave me the honor of a lifetime by letting me express my thoughts in unison with telling the brilliant stories of professionals around the world. As I wrote endlessly 24 hours a day I realized that our world is full of hope and real promise. I realized that it wasnt about war, ideology and the pursuit of global domination. I realized that in the pages of this great book great things were about to happen if only these stories can be made public. I realized that I had the opportunity of a lifetime by expressing the Humanitarian attributes that these professionals continually made. After many years of writing I realized that the Remington Company had a distinct and noble purpose and perhaps we could not change the present but we could certainly try to change our future. With that we created our Mentorship Program which gets these prolific stories out to the children. We wrote the stories with zest but never crossed the line of respect or dignity. We wished to capture the hearts of our audience and prove to them that giving was not an option but more so our duty as life forms on our planet. Today our book has a theme Inspiring the youth of America. This theme was our way of telling the world Lets hold hands and prepare our children for a better life. today I continue to write for the Registry. My life has irrevocably changed for the better. I volunteer for any thing all the time. I enjoy moments of quiet and the appreciation of our environment. I read these biographies in amazement as everyone else does and it never seems to get uneventful. Either way I sincerely hope you enjoy these biographies and use them to strengthen your spirit and confidence about our existence as a species on this planet. I patiently wait for divine intervention in order to write my next biography and am happy to serve the brilliant members of the Remington Registry of Outstanding Professionals.
Author : Manohar A Potdar
Publisher : Pharmamed Press
ISBN 13 : 9789387593442
Total Pages : 856 pages
Book Rating : 4.5/5 (934 download)
Download or read book CGMP Current Good Manufacturing Practices for Pharmaceuticals written by Manohar A Potdar and published by Pharmamed Press. This book was released on 2019-07 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.
