CAPA in the Pharmaceutical and Biotech Industries

Written By J Rodriguez
CAPA in the Pharmaceutical and Biotech Industries
  • Publsiher : Elsevier
  • Release : 08 December 2015
  • ISBN : 1908818379
  • Pages : 248 pages
  • Rating : /5 from reviews
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Download or read book entitled CAPA in the Pharmaceutical and Biotech Industries by author: J Rodriguez which was release on 08 December 2015 and published by Elsevier with total page 248 pages . This book available in PDF, EPUB and Kindle Format. 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

CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries
  • Author : J Rodriguez
  • Publisher : Elsevier
  • Release Date : 2015-12-08
  • Total pages : 248
  • ISBN : 1908818379
GET BOOK

Summary : 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 ...

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
  • Author : Lanju Zhang
  • Publisher : Springer
  • Release Date : 2016-01-13
  • Total pages : 698
  • ISBN : 1908818379
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Summary : This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together ...

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
  • Total pages : 274
  • ISBN : 1908818379
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Summary : 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 ...

Stem Cell Bioprocessing

Stem Cell Bioprocessing
  • Author : Tiago G Fernandes,Maria Margarida Diogo,Joaquim M. S. Cabral
  • Publisher : Elsevier
  • Release Date : 2013-11-15
  • Total pages : 236
  • ISBN : 1908818379
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Summary : 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 ...

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 362
  • ISBN : 1908818379
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Summary : 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 ...

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • Total pages : 300
  • ISBN : 1908818379
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Summary : 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 ...

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release Date : 2014-08-22
  • Total pages : 780
  • ISBN : 1908818379
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Summary : 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 ...

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
  • Author : Vandana Patravale,Prajakta Dandekar,Ratnesh Jain
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • Total pages : 244
  • ISBN : 1908818379
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Summary : 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 ...

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
  • Total pages : 582
  • ISBN : 1908818379
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Summary : 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 ...

Marine Enzymes for Biocatalysis

Marine Enzymes for Biocatalysis
  • Author : Antonio Trincone
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Total pages : 576
  • ISBN : 1908818379
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Summary : Marine bioprospecting is a highly topical subject - in both applied and basic research - but, as yet, the marine ecosystem is a relatively unexplored source of natural bioactive substances with potential therapeutic activity. This book addresses the use of marine enzymes in biocatalysis through a series of chapters from ...

Ocular Transporters and Receptors

Ocular Transporters and Receptors
  • Author : Ashim K Mitra
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 276
  • ISBN : 1908818379
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Summary : 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 ...

Bacterial Cellular Metabolic Systems

Bacterial Cellular Metabolic Systems
  • Author : K. Shimizu
  • Publisher : Elsevier
  • Release Date : 2013-03-26
  • Total pages : 496
  • ISBN : 1908818379
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Summary : 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 ...

A Biotech Manager s Handbook

A Biotech Manager s Handbook
  • Author : M O'Neill,M M Hopkins
  • Publisher : Elsevier
  • Release Date : 2012-05-02
  • Total pages : 414
  • ISBN : 1908818379
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Summary : 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 ...

Quality Assurance

Quality Assurance
  • Author : G Welty
  • Publisher : Elsevier
  • Release Date : 2013-06-30
  • Total pages : 374
  • ISBN : 1908818379
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Summary : 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 ...

Drug Biomembrane Interaction Studies

Drug Biomembrane Interaction Studies
  • Author : Rosario Pignatello
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 440
  • ISBN : 1908818379
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Summary : The design and development of drugs and new pharmaceutical formulations require a full characterization of the chemical and physicochemical events occurring at the level of the single active ingredients or excipients, as well as their reciprocal interaction. Thermal analysis techniques are among the most widely used methods to achieve this; ...