Orange Handbook of Internal Auditing for Pharmaceutical Industry PDF Download
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Author: Dr. Naveed Naeem Quadri
Publisher: OrangeBooks Publication
ISBN:
Category : Business & Economics
Languages : en
Pages : 98
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Book Description
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.
Author: Dr. Naveed Naeem Quadri
Publisher: OrangeBooks Publication
ISBN:
Category : Business & Economics
Languages : en
Pages : 98
Get Book Here
Book Description
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.
Author: K. H. Spencer Pickett
Publisher: John Wiley & Sons
ISBN: 0470662131
Category : Business & Economics
Languages : en
Pages : 1091
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Book Description
The first edition of The Internal Auditing Handbook received wide acclaim from readers and became established as one of the definitive publications on internal auditing. The second edition was released soon after to reflect the rapid progress of the internal audit profession. There have been a number of significant changes in the practice of internal auditing since publication of the second edition and this revised third edition reflects those changes. The third edition of The Internal Auditing Handbook retains all the detailed material that formed the basis of the second edition and has been updated to reflect the Institute of Internal Auditor’s (IIA) International Standards for the Professional Practice of Internal Auditing. Each chapter has a section on new developments to reflect changes that have occurred over the last few years. The key role of auditors in reviewing corporate governance and risk management is discussed in conjunction with the elevation of the status of the chief audit executive and heightened expectations from boards and audit committees. Another new feature is a series of multi-choice questions that have been developed and included at the end of each chapter. This edition of The Internal Auditing Handbook will prove to be an indispensable reference for both new and experienced auditors, as well as business managers, members of audit committees, control and compliance teams, and all those who may have an interest in promoting corporate governance.
Author: George B. Moseley III
Publisher: Jones & Bartlett Publishers
ISBN: 1449639658
Category : Business & Economics
Languages : en
Pages : 598
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Book Description
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
Author: Martin Stephens
Publisher: Pharmaceutical Press
ISBN: 9780853695028
Category : Medical
Languages : en
Pages : 316
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Book Description
Author:
Publisher:
ISBN:
Category : Auditing, Internal
Languages : en
Pages : 222
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Book Description
Author: Rose Hightower
Publisher: John Wiley & Sons
ISBN: 0470287179
Category : Business & Economics
Languages : en
Pages : 286
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Book Description
Drawing on her many years as a consultant to numerous companies big and small, author Rose Hightower infuses Internal Controls Policies and Procedures with her wealth of experience and knowledge. Instead of reinventing the wheel, your company can use this useful how-to manual to quickly and effectively put a successful program of internal controls in place. Complete with flowcharts and checklists, this essential desktop reference is a best practices model for establishing and enhancing your organization's control framework. These manuals are favorites for organizations and companies that need a foundation and grounding to ensure an internal control posture of integrity, credibility, method, process and process: or a reminder of its importance. URLs were included when first published to encourage the dissemination and distribution of relevant chapters to those interested and in charge of the specific departments. Although times have changed, the principles professed are sound and solid for today’s accounting and business environment. Implementing these cornerstones will produce a principled manageable approach. These manuals can be used by accounting individuals, finance departments, sole proprietor businesses, large corporations, accounting / auditing students and any others interested in specific topics or general disciplines. The discipline for the oversight processes and procedures are important when introducing or implementing auditing practices whether in accounting or throughout the organization. These manuals should be used together to provide the basics when setting up a department or specific process discipline, for learning about the strengths, weaknesses and opportunities within the specific focus areas.
Author: Rameshwar Verma
Publisher: OrangeBooks Publication
ISBN:
Category : Business & Economics
Languages : en
Pages : 196
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Book Description
The Book “Basic concepts of Track and Trace System for Pharmaceutical Industry” is collection of my experience and guide of my Team, the book gives the clear understanding of serialization processes, Global standards, Regulatory requirements and supply chain visibility using various technologies like RFID, Al, IoT and Blockchain etc. Complete understanding of regulatory requirements like DSCSA, EU FMD along with emerging markets. Concise explanations of terminologies. The book basic for beginner and expert the peoples. Who’s want to know all about the track and trace system.
Author: Mahmoud Aljurf
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 181
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Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Author: Alison M. Beaney
Publisher:
ISBN: 9780857113078
Category : Asepsis and antisepsis
Languages : en
Pages : 0
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Book Description
Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.
Author:
Publisher:
ISBN:
Category : Associations, institutions, etc
Languages : en
Pages : 584
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Book Description
