Pharmaceutical and Medical Device Validation by Experimental Design PDF Download

Author: Lynn D Torbeck
Publisher: CRC Press
ISBN: 1420055704
Category : Medical
Languages : en
Pages : 272

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Book Description
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap

Author: Eugenia Gabriela Carrillo-Cedillo
Publisher:
ISBN: 9781799896142
Category : Drugs
Languages : en
Pages :

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Book Description
"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--

Author: Lynn D. Torbeck
Publisher:
ISBN: 9781933722382
Category : Experimental design
Languages : en
Pages : 200

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Book Description

Author: Douglas J. Ball
Publisher: John Wiley & Sons
ISBN: 0470173653
Category : Science
Languages : en
Pages : 702

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Book Description
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382

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Book Description
Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. - Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device - Offers a practical approach to recent developments in the design and manufacture of medical devices - Presents a topic that is the focus of research in many important universities and centres of research worldwide

Author: Ajay Babu Pazhayattil
Publisher: Springer
ISBN: 3030024725
Category : Medical
Languages : en
Pages : 99

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Book Description
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

Author: Carrillo-Cedillo, Eugenia Gabriela
Publisher: IGI Global
ISBN: 179981520X
Category : Science
Languages : en
Pages : 429

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Book Description
Statistics is a key characteristic that assists a wide variety of professions including business, government, and factual sciences. Companies need data calculation to make informed decisions that help maintain their relevance. Design of experiments (DOE) is a set of active techniques that provides a more efficient approach for industries to test their processes and form effective conclusions. Experimental design can be implemented into multiple professions, and it is a necessity to promote applicable research on this up-and-coming method. Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications is a pivotal reference source that seeks to increase the use of design of experiments to optimize and improve analytical methods and productive processes in order to use less resources and time. While highlighting topics such as multivariate methods, factorial experiments, and pharmaceutical research, this publication is ideally designed for industrial designers, research scientists, chemical engineers, managers, academicians, and students seeking current research on advanced and multivariate statistics.

Author: Marie Teixeira
Publisher: CRC Press
ISBN: 9780203909386
Category : Medical
Languages : en
Pages : 258

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Book Description
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Author: Ludwig Huber
Publisher: CRC Press
ISBN: 9780849382673
Category : Medical
Languages : en
Pages : 0

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Book Description
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824794590
Category : Science
Languages : en
Pages : 1114

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Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."