CAPA in the Pharmaceutical and Biotech Industries

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  • Publisher : Woodhead Publishing Limited
  • Release : 13 March 2015
  • ISBN : 1907568581
  • Page : 248 pages
  • Rating : 4.5/5 from 103 voters

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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately

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CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries
  • Author : Jackelyn Rodriguez
  • Publisher : Woodhead Publishing Limited
  • Release Date : 2015-03-13
  • ISBN : 1907568581
GET THIS BOOKCAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes

CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries
  • Author : J Rodriguez
  • Publisher : Elsevier
  • Release Date : 2015-12-08
  • ISBN : 9781908818379
GET THIS BOOKCAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes

Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen for Pharmaceutical, Medical Device and Biotech Industries
  • Author : Shruti Bhat
  • Publisher : ISBN Canada
  • Release Date : 2017-04-05
  • ISBN : 1988663040
GET THIS BOOKKaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen

From Plant Genomics to Plant Biotechnology

From Plant Genomics to Plant Biotechnology
  • Author : Palmiro Poltronieri,Natalija Burbulis,Corrado Fogher
  • Publisher : Elsevier
  • Release Date : 2013-08-31
  • ISBN : 9781908818478
GET THIS BOOKFrom Plant Genomics to Plant Biotechnology

With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory, the roles

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • ISBN : 9781908818508
GET THIS BOOKFormulation tools for Pharmaceutical Development

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • ISBN : 9781908818324
GET THIS BOOKComputer-Aided Applications in Pharmaceutical Technology

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • ISBN : 9781908818638
GET THIS BOOKSterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release Date : 2014-08-22
  • ISBN : 9781908818287
GET THIS BOOKTransporters in Drug Discovery and Development

Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
  • Author : Vandana Patravale,Prajakta Dandekar,Ratnesh Jain
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • ISBN : 9781908818195
GET THIS BOOKNanoparticulate Drug Delivery

Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use

A Biotech Manager's Handbook

A Biotech Manager's Handbook
  • Author : M O'Neill,M M Hopkins
  • Publisher : Elsevier
  • Release Date : 2012-05-02
  • ISBN : 9781908818157
GET THIS BOOKA Biotech Manager's Handbook

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to

Open Source Software in Life Science Research

Open Source Software in Life Science Research
  • Author : Lee Harland,Mark Forster
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • ISBN : 9781908818249
GET THIS BOOKOpen Source Software in Life Science Research

The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four

Ocular Transporters and Receptors

Ocular Transporters and Receptors
  • Author : Ashim K Mitra
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • ISBN : 9781908818317
GET THIS BOOKOcular Transporters and Receptors

Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this

Bacterial Cellular Metabolic Systems

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  • Author : K. Shimizu
  • Publisher : Elsevier
  • Release Date : 2013-03-26
  • ISBN : 9781908818201
GET THIS BOOKBacterial Cellular Metabolic Systems

The metabolic regulation of a cell system is of critical importance in systems biology, and a robust model of these mechanisms is essential in predicting the effects on the metabolism of both the culture environment and the knockout of specific genes. Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches.

Stem Cell Bioprocessing

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  • Author : Tiago G Fernandes,Maria Margarida Diogo,Joaquim M. S. Cabral
  • Publisher : Elsevier
  • Release Date : 2013-11-15
  • ISBN : 9781908818300
GET THIS BOOKStem Cell Bioprocessing

Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion, and stem cell separation techniques such as isolation and purification are discussed. Basic definitions are provided concerning the different types of stem cells, from adult stem cells to the more recent induced pluripotent stem cells. The main characteristics of these different

Quality Assurance

Quality Assurance
  • Author : G Welty
  • Publisher : Elsevier
  • Release Date : 2013-06-30
  • ISBN : 9781908818621
GET THIS BOOKQuality Assurance

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The