This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!
This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!
This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as...
Filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum...
Arising from the author's experience as a practicing CPA, this book is quite different from other research in this field, as it confronts the subject of audit quality from a pragmatic perspective...
There are as many views on audits and auditing auditing as there are people who have ever thought about the subject and the process. Any author writing about it is faced with some common problems,...
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