Orange Handbook Of Internal Auditing For Pharmaceutical Industry

Orange Handbook of Internal Auditing for Pharmaceutical Industry

This is book is written to understand concept of Internal Audit in very easy and simple way, focusing on facilities, operations, quality systems and procedures to ensure the compliance with respect to current Good Manufacturing Practices (cGMP) and regulatory requirements and to recommend Corrective Actions for improvement / upgrade of Quality Management System (QMS) in pharmaceutical and other healthcare industry. Either you are auditor, auditee, student or representative from top management or any of pharmaceutical department, this book will help you to understand the process of auditing the pharmaceutical industry. To make learning simply, I have tried to make this book handy, short and simple. At appropriate place of book, motivational quotes from great personality have been added, which is one of unique concept for book of this kind. Hence this book is written as part of installments for GMP auditing concept, so first installment series is dedicated to internal audit, upcoming series will cover second party (Vendor audit) audits and third party independent (Audit by Regulatory agency) auditing organization.

Managing Legal Compliance in the Health Care Industry

Managing Legal Compliance in the Health Care Industry is a comprehensive text that prepares students for this increasingly critical field in health care administration. In three sections, this unique title first examines all the key laws and regulations that health care organizations must comply with. In section two, it explores in detail the seven essential ingredients for a good compliance program. In the final section, the book explains how the compliance program must be adapted to the special needs of different types of health care organizations. Designed for graduate level students in programs of public health, health administration, and law, the text is filled with highly practical information about the ways that legal violations occur and how good compliance programs function. Key Features: - Examines in detail the current laws and regulations with which all types of health care organizations must comply - Explore the seven essential ingredients for a good compliance program - Looks at compliance programs within twelve different types of health care organizations - References real world cases of fraud and abuse - Includes Study Questions and Learning Experiences in each chapter that are designed to encourage critical thinking

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