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Author: FDAnews
Publisher:
ISBN: 9781932074451
Category : Medical instruments and apparatus
Languages : en
Pages :
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Book Description
Author: FDAnews
Publisher:
ISBN: 9781932074451
Category : Medical instruments and apparatus
Languages : en
Pages :
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Book Description
Author:
Publisher: Washington Business Information
ISBN: 9781932074109
Category : Medical instruments and apparatus
Languages : en
Pages : 356
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Book Description
Author: Clifford Matthews
Publisher:
ISBN: 9780995676206
Category : Technology & Engineering
Languages : en
Pages : 354
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Book Description
This industry guide is intended for inspectors or other individuals involved in the source inspection of new construction of pressure vessels, heat exchangers, tanks, fabricated piping and other fixed equipment. Source inspections is a broad technical subject involving a wide variety of technologies and manufacturing capability. Large EPC contracts with multi-national manufacturing bring their own requirements for coordination, specification compliance and the quality of manufacturers. Worldwide the adoption of ASME, API, and EN codes in diverse industries helps to bring a sound technical base to specifications and the activities of source inspection. Part A: SOURCE INSPECTION OF FIXED EQUIPMENT The role of the source inspector; tactics of source inspection (how to do it); inspecting materials; inspecting NDE; inspecting pressure vessels; inspecting valves; inspecting structures and steelwork; inspecting surface preparation and painting;. Part B: API SIFE EXAM PREPARATION The API Individual Certificate Program; the API SIFE exam - what to expect; the SIFE body of knowledge and study guide; metallurgy and materials; non-destructive evaluation (NDE); welding processes; structural steelwork; pipework; pressure vessels; valves and components; pressure testing; surface preparation.
Author: John S. Adcock
Publisher: Interpharm CRC
ISBN: 9781574910469
Category : Medical
Languages : en
Pages : 185
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Book Description
Author: Almir Badnjević
Publisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441
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Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Author: United States. Food and Drug Administration. Division of Emergency and Investigational Operations
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 216
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
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Book Description
Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
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Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author: Brendan Cooper
Publisher: Createspace Independent Publishing Platform
ISBN: 9781548715328
Category :
Languages : en
Pages : 434
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Book Description
At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics- principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some area's exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included: Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 52
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Book Description
