FDA Biotechnology Inspection Guide
Author: United States. Food and Drug Administration
Publisher:
Published: 1991
Total Pages: 62
ISBN-13:
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Genetic Engineering News
Author:
Publisher:
Published: 2000
Total Pages: 748
ISBN-13:
DOWNLOAD EBOOKNewsletters in Print
Author: Gale Group
Publisher: Gale Cengage
Published: 2002-11-26
Total Pages: 1462
ISBN-13: 9780787665104
DOWNLOAD EBOOKWith descriptions of more than 12,000 newsletters in 4,000 different subject areas, this comprehensive resource is an invaluable research tool.
Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2008-03-11
Total Pages: 1386
ISBN-13: 0470259809
DOWNLOAD EBOOKThis handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Human resources for medical devices - the role of biomedical engineers
Author: World Health Organization
Publisher: World Health Organization
Published: 2017-05-09
Total Pages: 0
ISBN-13: 9789241565479
DOWNLOAD EBOOKThis publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Medical Device Design
Author:
Publisher: Academic Press
Published: 2012-12-17
Total Pages: 369
ISBN-13: 0123919436
DOWNLOAD EBOOKThis book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Analytical Method Validation and Instrument Performance Verification
Author: Chung Chow Chan
Publisher: John Wiley & Sons
Published: 2004-04-23
Total Pages: 320
ISBN-13: 047146371X
DOWNLOAD EBOOKValidation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publisher: CRC Press
Published: 2006-05-30
Total Pages: 1144
ISBN-13: 1420009419
DOWNLOAD EBOOKSpanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Pharmaceutical Dosage Forms and Drug Delivery Systems
Author: Howard C. Ansel
Publisher: Lippincott Williams & Wilkins
Published: 1999
Total Pages: 0
ISBN-13: 9780683305722
DOWNLOAD EBOOKThis work covers the entire scope of pharmaceutics, from the basics of drug dosage and routes of administration to the finer points of drug discovery, drug product development, legislation and regulations governing quality standards and product approval for marketing.
Sterile Drug Products
Author: Michael J. Akers
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 517
ISBN-13: 1420020560
DOWNLOAD EBOOKSterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
