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Handbook of Investigation and Effective CAPA Systems
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from t...
Human Error Reduction in Manufacturing
For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples ...
Quality Risk Management in the FDA-Regulated Industry
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is ...
The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadia...
Hard Measures
An explosive memoir about the creation and implementation of the controversial Enhanced Interrogation Techniques by the former Chief Operations Officer for the CIA's Counterterrorism Center.
Predictive Control of Power Converters and Electrical Drives
Describes the general principles and current research into Model Predictive Control (MPC); the most up-to-date control method for power converters and drives The book starts with an introduction to the subject before the first chapter on classical control methods for power converters and drives. This covers classical converter control methods and classical electrical drives control methods. The next chapter on Model predictive control first looks at predictive control methods for power converters and drives and presents the basic principles of MPC. It then looks at MPC for power electronics and drives. The third chapter is on predictive control applied to power converters. It discusses: cont...
Statistical Process Control for the FDA-Regulated Industry
The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. A...
Quality Culture in the Pharmaceutical Industry
Why so many pharmaceutical companies are struggling to meet GMP and other regulatory requirements?The reason is clear: because they are trying to improve their quality management systems by fixing symptoms rather than by attacking the fundamental and primary root cause of their problems which is the lack of adequate quality and compliance culture.The purpose of this book is to provide those leaders and senior managers with a clear roadmap to solve their regulatory problems and to return to the route of compliance by implementing a strong, positive quality and compliance culture. The recipe is simple: all you need is good people (including good leaders and senior managers), good procedures an...
