Wiley Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives

From the Inside Flap Everything staff members in bioanalytical/analytical laboratories and quality assurance unit need to know about technical expertise and regulatory compliance This book provides much-needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical, and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data.Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. Coverage includes:International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO, EMEA, and EURequirements, objectives, and implementation of GLP and GxP quality systemsFacility and personnel infrastructure and qualificationTechniques for modern bioanalytical / analytical sample preparation and essential concepts in extraction chemistry and separation mechanismsSpecific strategies for the efficient use of laboratory automation with high throughputInstrumental analysis for hyphenated techniques such as LC-MS/MS and so onImportant laboratory applications of Ligand Binding Assays (LBAs) andbiomarker assaysA must-have for scientists, graduate students, and quality assurance managers in bioanalytical laboratories, Regulated Bioanalytical Laboratories is also an essential reference for anyone interested in the overall technical know-how, regulatory, and quality assurance trends in the field. Product Description This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations. Review   From the Back Cover Everything staff members in bioanalytical/analytical laboratories and quality assurance unit need to know about technical expertise and regulatory compliance This book provides much-needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical, and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data.Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. Coverage includes:International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO, EMEA, and EURequirements, objectiv