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Author : Institute of Validation Technology
Publisher :
ISBN 13 :
Total Pages : 37 pages
Book Rating : 4.:/5 (713 download)
Download or read book A Pocket Guide to CGMP Sampling written by Institute of Validation Technology and published by . This book was released on 2006 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 37 pages
Book Rating : 4.:/5 (928 download)
Download or read book A Pocket Guide to CGMP Sampling written by and published by . This book was released on 2006 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Julie Meeson
Publisher : Inst of Clinical Research
ISBN 13 : 1905238673
Total Pages : 73 pages
Book Rating : 4.9/5 (52 download)
Download or read book The Pocket Guide to the EU Directives for Clinical Research written by Julie Meeson and published by Inst of Clinical Research. This book was released on 2009 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : D. Nally Joseph
Publisher : CRC Press
ISBN 13 : 0824741935
Total Pages : 752 pages
Book Rating : 4.8/5 (247 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals written by D. Nally Joseph and published by CRC Press. This book was released on 2000-10-12 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.
Author : Todd Coffey
Publisher : CRC Press
ISBN 13 : 1498721419
Total Pages : 358 pages
Book Rating : 4.4/5 (987 download)
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by CRC Press. This book was released on 2018-05-16 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.4/5 (72 download)
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Victor A. Bernstam
Publisher : CRC Press
ISBN 13 : 0429530749
Total Pages : 391 pages
Book Rating : 4.4/5 (295 download)
Download or read book Pocket Guide to Gene Level Diagnostics in Clinical Practice written by Victor A. Bernstam and published by CRC Press. This book was released on 2019-04-23 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pocket Guide to Gene Level Diagnostics in Clinical Practice is an abbreviated, pocket-size, quick-reference guide that provides a point-by-point synopsis of the vast wealth of information contained in CRC Handbook of Gene Level Diagnostics in Clinical Practice. All sections and subsections in the Pocket Guide are cross-referenced to corresponding p
Author : Phillip A. Carson
Publisher : Royal Society of Chemistry
ISBN 13 : 0854048340
Total Pages : 657 pages
Book Rating : 4.8/5 (54 download)
Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Phillip A. Carson and published by Royal Society of Chemistry. This book was released on 2007 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Mindy J. Allport-Settle
Publisher : Pharmalogika
ISBN 13 : 9780982147603
Total Pages : 686 pages
Book Rating : 4.1/5 (476 download)
Download or read book Good Manufacturing Practice (GMP) Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author : Philip Carson
Publisher : Royal Society of Chemistry
ISBN 13 : 1847557724
Total Pages : 657 pages
Book Rating : 4.8/5 (475 download)
Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author : Joseph D. Nally
Publisher : CRC Press
ISBN 13 : 1420020935
Total Pages : 418 pages
Book Rating : 4.4/5 (2 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Author :
Publisher :
ISBN 13 : 9781563959851
Total Pages : 552 pages
Book Rating : 4.9/5 (598 download)
Download or read book CFR Mini-handbook 2018 written by and published by . This book was released on 2018 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781683086857
Total Pages : 546 pages
Book Rating : 4.0/5 (868 download)
Download or read book The CMS Hospital Conditions of Participation and Interpretive Guidelines written by and published by . This book was released on 2017-11-27 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: In addition to reprinting the PDF of the CMS CoPs and Interpretive Guidelines, we include key Survey and Certification memos that CMS has issued to announced changes to the emergency preparedness final rule, fire and smoke door annual testing requirements, survey team composition and investigation of complaints, infection control screenings, and legionella risk reduction.
Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Velio Bocci
Publisher : Springer Science & Business Media
ISBN 13 : 904819234X
Total Pages : 330 pages
Book Rating : 4.0/5 (481 download)
Download or read book OZONE written by Velio Bocci and published by Springer Science & Business Media. This book was released on 2010-10-05 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oxygen-Ozone therapy is a complementary approach less known than homeopathy and acupuncture because it has come of age only three decades ago. This book clarifies that, in the often nebulous field of natural medicine, the biological bases of ozone therapy are totally in line with classical biochemistry, physiological and pharmacological knowledge. Ozone is an oxidizing molecule, a sort of super active oxygen, which, by reacting with blood components generates a number of chemical messengers responsible for activating crucial biological functions such as oxygen delivery, immune activation, release of hormones and induction of antioxidant enzymes, which is an exceptional property for correcting the chronic oxidative stress present in atherosclerosis, diabetes and cancer. Moreover, by inducing nitric oxide synthase, ozone therapy may mobilize endogenous stem cells, which will promote regeneration of ischemic tissues. The description of these phenomena offers the first comprehensive picture for understanding how ozone works and why. When properly used as a real drug within therapeutic range, ozone therapy does not only does not procure adverse effects but yields a feeling of wellness. Half the book describes the value of ozone treatment in several diseases, particularly cutanious infection and vascular diseases where ozone really behaves as a “wonder drug”. The book has been written for clinical researchers, physicians and ozone therapists, but also for the layman or the patient interested in this therapy.
Author : Hiram F. Gilbert
Publisher : McGraw Hill Professional
ISBN 13 : 9780071356572
Total Pages : 366 pages
Book Rating : 4.3/5 (565 download)
Download or read book Basic Concepts in Biochemistry: A Student's Survival Guide written by Hiram F. Gilbert and published by McGraw Hill Professional. This book was released on 2000 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Basic Concepts in Biochemistry has just one goal: to review the toughest concepts in biochemistry in an accessible format so your understanding is through and complete."--BOOK JACKET.
