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

Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen for Pharmaceutical, Medical Device and Biotech Industries
  • Author : Shruti Bhat
  • Publisher : ISBN Canada
  • Release : 05 April 2017
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

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

The Certified Pharmaceutical GMP Professional Handbook, Second Edition
  • Author : Mark Allen Durivage
  • Publisher : Quality Press
  • Release : 26 May 2016
GET THIS BOOKThe Certified Pharmaceutical GMP Professional Handbook, Second Edition

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and

Applying Lean Six Sigma in the Pharmaceutical Industry

Applying Lean Six Sigma in the Pharmaceutical Industry
  • Author : Bikash Chatterjee
  • Publisher : CRC Press
  • Release : 08 April 2016
GET THIS BOOKApplying Lean Six Sigma in the Pharmaceutical Industry

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug

Encapsulation of Active Molecules and Their Delivery System

Encapsulation of Active Molecules and Their Delivery System
  • Author : Shirish Hari Sonawane,Bharat A. Bhanvase,Manickam Sivakumar
  • Publisher : Elsevier
  • Release : 24 March 2020
GET THIS BOOKEncapsulation of Active Molecules and Their Delivery System

Encapsulation of Active Molecules and Their Delivery System covers the key methods of preparation of encapsulation, as well as release mechanisms and their applications in food, biotechnology, metal protection, drug delivery, and micronutrients delivery in agriculture. The book also provides real-life examples of applications in food and other industries. Sections encompasses (i) Synthesis and characterization methods of micro- and nanocarriers as the delivery systems, (ii) Up-to-date encapsulation techniques in the areas of pharmaceuticals, nutraceuticals and corrosion, (iii) The release methods

The Science and Business of Drug Discovery

The Science and Business of Drug Discovery
  • Author : Edward D. Zanders
  • Publisher : Springer Nature
  • Release : 11 December 2020
GET THIS BOOKThe Science and Business of Drug Discovery

The Science and Business of Drug Discovery is written for those who want to learn about the biopharmaceutical industry and its products whatever their level of technical knowledge. Its aim is to demystify the jargon used in drug development, but in a way that avoids over simplification and the resulting loss of key information. Each of the twenty chapters is illustrated with figures and tables which clarify some of the more technical points being made. Also included is a drug

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems
  • Author : Oliver Schmidt
  • Publisher : CRC Press
  • Release : 30 April 2000
GET THIS BOOKPharmaceutical Quality Systems

When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
  • Author : Terry Jacobs,Andrew A. Signore
  • Publisher : CRC Press
  • Release : 18 August 2016
GET THIS BOOKGood Design Practices for GMP Pharmaceutical Facilities, Second Edition

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Do Vaccines Cause That?!

Do Vaccines Cause That?!
  • Author : Martin G. Myers,Diego Pineda
  • Publisher : i4ph
  • Release : 09 May 2021
GET THIS BOOKDo Vaccines Cause That?!

Almost 70% of parents who refuse to vaccinate their children do so because they believe vaccines may cause harm. Indeed vaccines have been blamed for causing asthma, autism, diabetes, and many other conditions most of which have causes that are incompletely understood. Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns provides parents with clearly understandable, science-based information about vaccines, immunization, and vaccine safety.

Commercial Biotechnology

Commercial Biotechnology
  • Author : United States. Congress. Office of Technology Assessment
  • Publisher : Elsevier Science Limited
  • Release : 09 May 1984
GET THIS BOOKCommercial Biotechnology

Overzichtsrapportage van de industriele toepassing van recombinant DNA, celfusie en nieuwe bioproces-technieken, waarin na de Verenigde Staten als belangrijkste Japan, West-Duitsland, Groot-Brittannie, Zwitserland en Frankrijk de leidende rol spelen

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

The Oxford Handbook of the Economics of the Biopharmaceutical Industry
  • Author : Patricia M. Danzon,Sean Nicholson
  • Publisher : Oxford University Press
  • Release : 12 April 2012
GET THIS BOOKThe Oxford Handbook of the Economics of the Biopharmaceutical Industry

The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms

Root Cause Analysis Handbook

Root Cause Analysis Handbook
  • Author : ABS Consulting,Lee N. Vanden Heuvel,Donald K. Lorenzo,Laura O. Jackson,Walter E. Hanson,James J. Rooney,David A. Walker
  • Publisher : Rothstein Publishing
  • Release : 01 October 2014
GET THIS BOOKRoot Cause Analysis Handbook

Are you trying to improve performance, but find that the same problems keep getting in the way? Safety, health, environmental quality, reliability, production, and security are at stake. You need the long-term planning that will keep the same issues from recurring. Root Cause Analysis Handbook: A Guide to Effective Incident Investigation is a powerful tool that gives you a detailed step-by-step process for learning from experience. Reach for this handbook any time you need field-tested advice for investigating, categorizing, reporting