GALP Regulatory Handbook


Book Description

The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.




Wiley CIAexcel Exam Review 2018, Part 3


Book Description

WILEY CIAexcel EXAM REVIEW 2018 THE SELF-STUDY SUPPORT YOU NEED TO PASS THE CIA EXAM Part 3: Internal Audit Knowledge Elements Provides comprehensive coverage based on the exam syllabus, along with multiple-choice practice questions with answers and explanations Deals with governance and business ethics, risk management, information technology, and the global business environment Features a glossary of CIA Exam terms—good source for candidates preparing for and answering the exam questions Assists the CIA Exam candidate in successfully preparing for the exam Based on the CIA body of knowledge developed by The Institute of Internal Auditors (IIA), Wiley CIAexcel Exam Review 2018 learning system provides a student-focused and learning-oriented experience for CIA candidates. Passing the CIA Exam on your first attempt is possible. We'd like to help. Feature section examines the topics of Governance and Business Ethics, Risk Management, Organizational Structure and Business Processes and Risks, Communications, Management and Leadership Principles, IT and Business Continuity, Financial Management, and Global Business Environment




Wiley CIAexcel Exam Review 2015, Part 3


Book Description

Master internal audit knowledge elements for the CIA exam Wiley CIAexcel Exam Review 2015: Part 3, Internal Audit Knowledge Elements is a comprehensive yet approachable reference that prepares you for the third part of the Certified Internal Auditor (CIA) examination. Brimming with essential concepts and practice test questions, this test prep resource is the most comprehensive of its kind on the market. With each page you will explore key subject areas, including business processes, financial accounting and finance, managerial accounting, regulatory, legal, and economics, and information technology. All of these subject areas are expertly tied to the topic of internal audit knowledge elements, and all ideas—both fundamental and complex—are presented in an easy-to-read yet thorough manner. Holding the designation of CIA will take your career to the next level, as passing the CIA exam speaks volumes about your professional skills and expertise. Leveraging the right study materials when preparing for the CIA exam is critical, as the topics that may be covered on the test are many in number. This resource presents these topics from a student's perspective, providing the details you need to master challenging concepts and practices. Access comprehensive preparation materials for the third part of the CIA exam Explore essential internal audit knowledge elements, including key concepts and practices Answer hundreds of practice test questions to gauge your progress and focus your study sessions Improve your proficiency, understanding, and awareness of key concepts tested by the CIA examination Wiley CIAexcel Exam Review 2015: Part 3, Internal Audit Knowledge Elements is an invaluable resource for internal auditors, chief audit executives, audit managers, and staff members who are pursuing the CIA designation.




Validation Compliance Annual


Book Description

"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."




Wiley CIA Exam Review 2013, Internal Audit Knowledge Elements


Book Description

The most comprehensive Certified Internal Auditor Exam preparation guide available One exam, three volumes of preparation. Here is the best source to help you prepare for the Certified Internal Auditor (CIA) exam covering the new syllabus, effective 2013. Wiley CIA Exam Review, Volume 3: Business Analysis and Information Technology addresses topics such as governance and business ethics; risk management; organizational structure, business processes, and risks; communication; management and leadership principles; information technology and business continuity; financial management; and global business environment. Includes fully developed theories and concepts, as opposed to superficial outlines found in other study guides Offers indicators that help candidates allot study time based on the weight given to each topic on the exam Indicates the level of difficulty expected for each topic on the exam as either "Awareness" or "Proficiency" so more time and effort can be assigned for the proficiency topics than for the awareness topics Presents highly comprehensive coverage of theory with glossary of technical terms Every volume in the Wiley CIA Exam Review series offers a successful learning system of visual aids and memorization techniques that enable certification candidates to form long-lasting impressions of covered material.




Good Laboratory Practice Regulations, Third Edition, Revised and Expanded


Book Description

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.




Wiley CIAexcel Exam Review 2016


Book Description

WILEY CIAexcel EXAM REVIEW 2016 THE SELF-STUDY SUPPORT YOU NEED TO PASS THE CIA EXAM Part 3: Internal Audit Knowledge Elements Provides comprehensive coverage based on the exam syllabus, along with sample practice multiple-choice questions with answers and explanations Deals with governance and business ethics, risk management, information technology, and the global business environment Features a glossary of CIA Exam terms, a good source for candidates preparing for and answering the exam questions Assists the CIA Exam candidate in successfully preparing for the exam Based on the CIA body of knowledge developed by The Institute of Internal Auditors (IIA), Wiley CIAexcel Exam Review 2016 learning system provides a student-focused and learning-oriented experience for CIA candidates. Passing the CIA Exam on your first attempt is possible. We'd like to help. Feature section examines the topics of Governance and Business Ethics, Risk Management, Organizational Structure and Business Processes and Risks, Communications, Management and Leadership Principles, IT and Business Continuity, Financial Management, and Global Business Environment




Validation Compliance Biannual 1996-1997


Book Description

This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.




Good Laboratory Practice Regulations, Revised and Expanded


Book Description

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g