CAPA 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 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

Produk Detail:

  • Author : J Rodriguez
  • Publisher : Elsevier
  • Pages : 248 pages
  • ISBN : 1908818379
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKCAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries
  • Author : J Rodriguez
  • Publisher : Elsevier
  • Release : 08 December 2015
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

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release : 10 April 2013
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

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release : 22 August 2014
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

Open Source Software in Life Science Research

Open Source Software in Life Science Research
  • Author : Lee Harland,Mark Forster
  • Publisher : Elsevier
  • Release : 31 October 2012
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

NMR Metabolomics in Cancer Research

NMR Metabolomics in Cancer Research
  • Author : Miroslava Čuperlović-Culf
  • Publisher : Elsevier
  • Release : 17 December 2012
GET THIS BOOKNMR Metabolomics in Cancer Research

The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics

From Plant Genomics to Plant Biotechnology

From Plant Genomics to Plant Biotechnology
  • Author : Palmiro Poltronieri,Natalija Burbulis,Corrado Fogher
  • Publisher : Elsevier
  • Release : 31 August 2013
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

Contract Research and Manufacturing Services (CRAMS) in India

Contract Research and Manufacturing Services (CRAMS) in India
  • Author : Milind Antani,Gowree Gokhale
  • Publisher : Elsevier
  • Release : 31 October 2012
GET THIS BOOKContract Research and Manufacturing Services (CRAMS) in India

The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
  • Author : Vandana Patravale,Prajakta Dandekar,Ratnesh Jain
  • Publisher : Elsevier
  • Release : 31 October 2012
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

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release : 31 October 2013
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

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release : 30 September 2013
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_

Bioinformatics for Biomedical Science and Clinical Applications

Bioinformatics for Biomedical Science and Clinical Applications
  • Author : K-H Liang
  • Publisher : Elsevier
  • Release : 31 July 2013
GET THIS BOOKBioinformatics for Biomedical Science and Clinical Applications

Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical

Matlab® in Bioscience and Biotechnology

Matlab® in Bioscience and Biotechnology
  • Author : Leonid Burstein
  • Publisher : Elsevier
  • Release : 05 June 2011
GET THIS BOOKMatlab® in Bioscience and Biotechnology

MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and

Ocular Transporters and Receptors

Ocular Transporters and Receptors
  • Author : Ashim K Mitra
  • Publisher : Elsevier
  • Release : 31 October 2013
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

Bacterial Cellular Metabolic Systems
  • Author : K. Shimizu
  • Publisher : Elsevier
  • Release : 26 March 2013
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

Stem Cell Bioprocessing
  • Author : Tiago G Fernandes,Maria Margarida Diogo,Joaquim M. S. Cabral
  • Publisher : Elsevier
  • Release : 15 November 2013
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