Documentation Basics that Support Good Manufacturing Practices PDF Download
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Author: Carol DeSain Publisher: Aster Publishing Corporation ISBN: 9780943330303 Category : Medical Languages : en Pages : 88
Book Description
The documentation system described in this text is designed to support Good Manufacturing Practices (GMP) in a medical manufacturing environment. However, the usefulness of the system can be extended to other areas of a corporation (development, clinicals, marketing, finance, as well as to many other unrelated, nonmedical industries). The principles & the decision making inherent in documentation system design remain the same, no matter what the product or business. The book describes the creation, use & control of the descriptive documents, data collection documents, numbering systems & data files that are appropriate for use in an industry subject to Good Manufacturing Practices. The text was written as a guideline for the individuals who must design the systems & work with them routinely. The descriptive documents presented in this book are designed to serve two purposes: to direction task-specific events & to educate the reader about the event in a manner that supports responsible decision making. It presents the major components of a GMP documentation system, gives examples of design, format & content, & explains how these components interact. $US42.95 plus shipping & tax where applicable. Call or write Advanstar Communications, Marketing Services; 7500 Old Oak Boulevard; Cleveland, OH 44130. 216-826-2839 or 800-598-6008.
Author: Carol DeSain Publisher: Aster Publishing Corporation ISBN: 9780943330303 Category : Medical Languages : en Pages : 88
Book Description
The documentation system described in this text is designed to support Good Manufacturing Practices (GMP) in a medical manufacturing environment. However, the usefulness of the system can be extended to other areas of a corporation (development, clinicals, marketing, finance, as well as to many other unrelated, nonmedical industries). The principles & the decision making inherent in documentation system design remain the same, no matter what the product or business. The book describes the creation, use & control of the descriptive documents, data collection documents, numbering systems & data files that are appropriate for use in an industry subject to Good Manufacturing Practices. The text was written as a guideline for the individuals who must design the systems & work with them routinely. The descriptive documents presented in this book are designed to serve two purposes: to direction task-specific events & to educate the reader about the event in a manner that supports responsible decision making. It presents the major components of a GMP documentation system, gives examples of design, format & content, & explains how these components interact. $US42.95 plus shipping & tax where applicable. Call or write Advanstar Communications, Marketing Services; 7500 Old Oak Boulevard; Cleveland, OH 44130. 216-826-2839 or 800-598-6008.
Author: Janet Gough Publisher: CRC Press ISBN: 1420025821 Category : Medical Languages : en Pages : 495
Book Description
A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective
Author: Gerardus Blokdyk Publisher: 5starcooks ISBN: 9781867313687 Category : Languages : en Pages : 308
Book Description
Have all basic functions of Good manufacturing practices been defined? For estimation problems, how do you develop an estimation statement? How do you monitor usage and cost? How will the Good manufacturing practices data be captured? What, related to, Good manufacturing practices processes does your organization outsource? This instant Good Manufacturing Practices self-assessment will make you the assured Good Manufacturing Practices domain master by revealing just what you need to know to be fluent and ready for any Good Manufacturing Practices challenge. How do I reduce the effort in the Good Manufacturing Practices work to be done to get problems solved? How can I ensure that plans of action include every Good Manufacturing Practices task and that every Good Manufacturing Practices outcome is in place? How will I save time investigating strategic and tactical options and ensuring Good Manufacturing Practices costs are low? How can I deliver tailored Good Manufacturing Practices advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Good Manufacturing Practices essentials are covered, from every angle: the Good Manufacturing Practices self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Good Manufacturing Practices outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Good Manufacturing Practices practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Good Manufacturing Practices are maximized with professional results. Your purchase includes access details to the Good Manufacturing Practices self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Good Manufacturing Practices Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
Author: Carol DeSain
Author: Carol DeSain
Author: Carol DeSain
Author: Janet Gough
Author: A. C. Lam
Author: Gerardus Blokdyk
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Author: 
Author: Betty Gibb
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Author: Brian P. Kujawa