Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes PDF Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762

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Book Description
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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes PDF Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762

Get Book Here

Book Description
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

Validation Standard Operating Procedures

Validation Standard Operating Procedures PDF Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1144

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Book Description
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition PDF Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062

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Book Description
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

Validation Compliance Annual

Validation Compliance Annual PDF Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824794590
Category : Science
Languages : en
Pages : 1114

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Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

A Practical Guide to Decontamination in Healthcare

A Practical Guide to Decontamination in Healthcare PDF Author: Gerald E. McDonnell
Publisher: John Wiley & Sons
ISBN: 1444330136
Category : Medical
Languages : en
Pages : 466

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Book Description
Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.

Validation of Aseptic Pharmaceutical Processes

Validation of Aseptic Pharmaceutical Processes PDF Author: Frederick J. Carleton
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 728

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Book Description


Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization

Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization PDF Author: Adam P. Fraise
Publisher: John Wiley & Sons
ISBN: 1444333259
Category : Medical
Languages : en
Pages : 626

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Book Description
The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Contemporary Esthetic Dentistry

Contemporary Esthetic Dentistry PDF Author: George A. Freedman
Publisher: Elsevier Health Sciences
ISBN: 0323088236
Category : Medical
Languages : en
Pages : 834

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Book Description
Covering both popular and advanced cosmetic procedures, Contemporary Esthetic Dentistry enhances your skills in the dental treatments leading to esthetically pleasing restorations. With over 1,600 full-color illustrations, this definitive reference discusses the importance of cariology and caries management, then covers essential topics such as ultraconservative dentistry, color and shade, adhesive techniques, anterior and posterior direct composites, and finishing and polishing. Popular esthetic treatment options are described in detail, including bleaching or tooth whitening, direct and porcelain veneers, and esthetic inlays and onlays. Coverage of advanced cosmetic procedures includes implants, perioesthethics, ortho-esthetics, and pediatric esthetics, providing a solid understanding of treatments that are less common but can impact patient outcomes. Developed by Dr. George A. Freedman, a renowned leader in the field, Contemporary Esthetic Dentistry also allows you to earn Continuing Education credits as you improve your knowledge and skills. - Continuing Education credits are available, allowing you to earn one to two CE credits per chapter. - Detailed coverage of popular esthetic procedures includes bleaching, direct and porcelain veneers, inlays and onlays, posts and cores, porcelain-fused-to-metal restorations, zirconium crowns and bridges, and complete dentures. - Coverage of advanced procedures includes implants, perioesthethics, ortho-esthetics, pediatric esthetics, and sleep-disordered breathing, providing a solid understanding of less-frequently encountered topics that impact the esthetic treatment plan and outcomes. - Coverage of key esthetic dentistry topics and fundamental skills includes cariology and caries management, understanding dental materials, photography, understanding and manipulating of color and shade, adhesive techniques, anterior and posterior direct composites, and finishing and polishing. - Over 1,600 full-color photos and illustrations help to clarify important concepts and techniques, and show treatments from beginning of the case to the final esthetic results. - Well-known and respected lead author George A. Freedman is a recognized author, educator, and speaker, and past president of the American Academy of Cosmetic Dentistry and co-founder of the Canadian Academy for Esthetic Dentistry. - Expert contributors are leading educators and practicing clinicians, including names such as Irvin Smigel (the father of esthetic dentistry), Chuck N. Maragos (the father of contemporary diagnostics), Wayne Halstrom (a pioneer in the area of dental sleep medicine), David Clark (one of the pioneers of the microscope in restorative dentistry and founder the Academy of Microscope Enhanced Dentistry), Edward Lynch (elected the most influential person in UK Dentistry in 2010 by his peers), Joseph Massad (creator, producer, director, and moderator of two of the most popular teaching videos on the subject of removable prosthodontics), Simon McDonald (founder and CEO of Triodent Ltd, an international dental manufacturing and innovations company), and many more!

Pharmaceutical Microbiology Principles and Applications

Pharmaceutical Microbiology Principles and Applications PDF Author:
Publisher: Nirali Prakashan
ISBN: 9788185790619
Category :
Languages : en
Pages : 456

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Book Description


Sterilization of Drugs and Devices

Sterilization of Drugs and Devices PDF Author: Fred M. Nordhauser
Publisher: Routledge
ISBN: 135141383X
Category : Medical
Languages : en
Pages : 718

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Book Description
Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the "how to validate" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.