Practical Process Validation

Practical Process Validation

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2016-07-11

Total Pages: 135

ISBN-13: 1636941028

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For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.


Process Validation the Ultimate Step-By-Step Guide

Process Validation the Ultimate Step-By-Step Guide

Author: Gerardus Blokdyk

Publisher: 5starcooks

Published: 2018-02-27

Total Pages: 126

ISBN-13: 9780655155508

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Have all basic functions of Process validation been defined? Which Process validation goals are the most important? Do the Process validation decisions we make today help people and the planet tomorrow? Who needs to know about Process validation ? What business benefits will Process validation goals deliver if achieved? Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role... In EVERY company, organization and department. Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Process validation investments work better. This Process validation All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Process validation Self-Assessment. Featuring 711 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Process validation improvements can be made. In using the questions you will be better able to: - diagnose Process validation projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Process validation and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Process validation Scorecard, you will develop a clear picture of which Process validation areas need attention. Your purchase includes access details to the Process validation self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. Your exclusive instant access details can be found in your book.


How to Perform Process Validation

How to Perform Process Validation

Author: David N. Muchemu

Publisher: cgmpuniversity.com

Published: 2009-10

Total Pages: 78

ISBN-13: 9781449512378

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THIS QUICK REFERENCE GUIDE IS MEANT TO HELP INDIVIDUALS PERFORMING PROCESS VALIDATION TO COVER ALL PHASES OF THE VALIDATION LIFE CYCLE,AND ALL ACTIVITIES REQUIRED PER PHASE IN ORDER TO BE IN COMPLIANCE