tailieunhanh - PHARMACEUTICAL 483 SAMPLER

If today an FDA auditor comes to your operation site, there is a that you will receive a dreaded 483-form full of non compliance observations. On 2010 the FDA issued 646 483’s to the pharmaceutical plants they visited. The question then becomes how to prepare or mitigate the probability of receiving a 483 observation? We believe that the best way to prepare for this occurrence is to gain experience from past examples of 483’s observations and use them as Business Cases Studies. Case studies illustrate psychological principles and Technical knowledge in a way that abstract generalizations and statistics cannot | PHARMACEUTICAL 483SAMPLER FIVE 483 OBSERVATIONS ON PHARMACEUTICAL SYSTEMS THAT YOU SHOULD KNOW EDITED BY DAVE CORTES PE 483 PHARMACEUTICAL SAMPLER All Rights Reserved. Copyright 2012 by Dave Cortes Cover Art 2012 Dave Cortes Cartoons 2012 Dave Cortes No original part of this publication may be reproduced or distributed in any form or by any means electronic or mechanical including photocopying recording or by any information or retrieval system without the prior written permission of the editor. Full 483 Forms are publicly available through the Electronic Freedom of Information Act fees may apply. For Information address 17101 Costa Esmeralda Ceiba . USA 00735 customer@ Contents 1. WHY THIS BOOK IS DIFFERENT .5 2. HOW THIS BOOK IS OBSERVATION 1 STATED OBSERVATION .15 CODE EDITOR COMMENTS .17 OBSERVATION 2 FACILITES AND EQUIPMENT 19 STATED OBSERVATION .19 CODE EDITOR COMMENTS .21 TIPS FOR JUSTIFICATIONS .22 OBSERVATION 3 QUALITY STATED OBSERVATION .23 CODE .

• Quản trị kinh doanh
• Dave Cortes
• busines
• business document
• business ebook
• business specific study
• business research
• Business research methods
• Lecture Business research methods
• Essentials of research
• Ethics in business research
• Research revelation
• Ethical violations
• Research design
• Research guides decisions
• Business decision
• Research process
• Research revelations
• Research should reduce risk
• Analysis of data
• Business research process
• Business research design
• Questionnaire design
• Ebook Business research method
• Information systems
• Theory building
• The business research process
• Business decisions
• Business intelligence
• Language of research
• Extraneous variables
• Research question
• Secondary data sources
• Qualitative research
• Data sources
• Observation studies
• Research industry works
• Internal research sources
• Research design descriptors
• Research in business
• Thinking like a researcher
• The research process
• The research question through secondary
• Ebook Research methods for business students
• Research methods for business students
• Research methods business students
• The nature of business
• The structure of this book
• Building and clarify the research
• Designing the research
• Multivariate analysis
• Multivariate techniques
• Presenting insights
• Written reports
• Presentation techniques
• Experiments challenge perceptions
• Evaluation of experiments
• Modes of data collection
• Dilemma for surveys
• Characteristics of measurement
• Levels of measurement
• Measurement scales
• Scaling Process
• Measurement skepticism
• Question content