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Author: Vinny R. Sastri Publisher: William Andrew ISBN: 9781455778843 Category : Technology & Engineering Languages : en Pages : 0
Book Description
Process Validation and Supplier Controls are hot-button issues for all stages of the design and manufacturing process, from the design and supply of polymers to product design and production. These procedures are especially critical in highly regulated sectors such as Medical Devices. Vinny Sastri uses his extensive experience in the plastics and Medical Device industries to provide an accessible and practical guide to implementing Process Validation and Supplier Control regimes on both sides of the supply chain: materials design and supply, and product design and manufacture. Best practice guidance is supported by a detailed explanation of the FDA and ISO regulatory frameworks for Process Validation and the Medical Device and Pharmaceuticals industries. Strp-by-step guidance is also provided regarding the validation process and related documentation. The importance of design and development, risk management and the process validation life cycle are highlighted, and the good automated manufacturing process (GAMP) model is discussed. In addition, statistical methods and modeling are covered. Sastri makes his content come to life by providing step-by-step instructions, flow charts and case studies from industry, along with templates and checklists that can be put to work straight away. Written for all stages in the process: raw material specification and compliance issues, process validation and design. Provides best practice guidance on the use of risk management in process validation Illustrates the importance of establishing critical process parameters and raw material specifications
Author: Vinny R. Sastri Publisher: William Andrew ISBN: 9781455778843 Category : Technology & Engineering Languages : en Pages : 0
Book Description
Process Validation and Supplier Controls are hot-button issues for all stages of the design and manufacturing process, from the design and supply of polymers to product design and production. These procedures are especially critical in highly regulated sectors such as Medical Devices. Vinny Sastri uses his extensive experience in the plastics and Medical Device industries to provide an accessible and practical guide to implementing Process Validation and Supplier Control regimes on both sides of the supply chain: materials design and supply, and product design and manufacture. Best practice guidance is supported by a detailed explanation of the FDA and ISO regulatory frameworks for Process Validation and the Medical Device and Pharmaceuticals industries. Strp-by-step guidance is also provided regarding the validation process and related documentation. The importance of design and development, risk management and the process validation life cycle are highlighted, and the good automated manufacturing process (GAMP) model is discussed. In addition, statistical methods and modeling are covered. Sastri makes his content come to life by providing step-by-step instructions, flow charts and case studies from industry, along with templates and checklists that can be put to work straight away. Written for all stages in the process: raw material specification and compliance issues, process validation and design. Provides best practice guidance on the use of risk management in process validation Illustrates the importance of establishing critical process parameters and raw material specifications
Author: Mark Allen Durivage Publisher: Quality Press ISBN: 0873899369 Category : Business & Economics Languages : en Pages : 168
Book Description
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
Author: Vernon Geckler Publisher: Wasatch Consulting Resources LLC ISBN: 0692835415 Category : Languages : en Pages : 441
Book Description
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
Author: Itay Abuhav Publisher: CRC Press ISBN: 1351000772 Category : Medical Languages : en Pages : 735
Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: Vinny R. Sastri Publisher: William Andrew ISBN: 0323265634 Category : Technology & Engineering Languages : en Pages : 324
Book Description
Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices Unique coverage of medical device regulatory aspects, supplier control and process validation Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices
Author: Susan Neadle Publisher: CRC Press ISBN: 1000874583 Category : Medical Languages : en Pages : 439
Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Kate McCormick Publisher: Routledge ISBN: 1317081390 Category : Business & Economics Languages : en Pages : 262
Book Description
A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Author: David N. Muchemu Publisher: AuthorHouse ISBN: 1434314685 Category : Guideline for industry Languages : en Pages : 150
Book Description
This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements
Author: Richard Podolak Publisher: John Wiley & Sons ISBN: 1119071089 Category : Technology & Engineering Languages : en Pages : 276
Book Description
The first and only comprehensive reference/solutions manual for managing food safety in low-moisture foods The first book devoted to an increasingly critical public health issue, Control of Salmonella and Other Bacterial Pathogens in Low-Moisture Foods reviews the current state of the science on the prevalence and persistence of bacterial pathogens in low-moisture foods and describes proven techniques for preventing food contamination for manufacturers who produce those foods. Many pathogens, such as Salmonella, due to their enhanced thermal resistance in dry environments, can survive the drying process and may persist for prolonged periods in low-moisture foods, especially when stored in refrigerated environments. Bacterial contamination of low-moisture foods, such as peanut butter, present a vexing challenge to food safety, and especially now, in the wake of widely publicized food safety related events, food processors urgently need up-to-date, practical information on proven measures for containing the risk of contamination. While much has been written on the subject, until now it was scattered throughout the world literature in scientific and industry journals. The need for a comprehensive treatment of the subject has never been greater, and now this book satisfies that need. Discusses a wide variety of foods and evaluates multiple processing platforms from the standpoint of process validation of all food safety objectives for finished food products Takes a practical approach integrating the latest scientific and technological advances in a handy working resource Presents all known sources and risk factors for pathogenic bacteria of concern in the manufacturing environment for low-moisture/water activity products Characterizes the persistence and thermal resistance of bacterial pathogens in both the environment and most low-moisture food products Control of Salmonella and Other Bacterial Pathogens in Low-Moisture Foods is a much-needed resource for food microbiologists and food industry scientists, as well as managers and executives in companies that produce and use low-moisture foods. It also belongs on the reference shelves of food safety regulatory agencies worldwide.
Author: Vinny R. Sastri
Author: Vinny R. Sastri
Author: Mark Allen Durivage
Author: Vernon Geckler
Author: Itay Abuhav
Author: 
Author: Vinny R. Sastri
Author: Susan Neadle
Author: Kate McCormick
Author: David N. Muchemu
Author: Richard Podolak