Regulation of science and experimentation Books
Royal Society of Chemistry Data Integrity and Data Governance: Practical
Book SynopsisData integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.Trade ReviewThe management of regulated industry needs to read all 600 pages in the book in order to set the standard for how every single person in their organization needs to work, themselves included. -- Siri H. Segalstad, Segalstad Consulting AS, NorwayThe book explains in detail all the aspects of the topics of data integrity, starting each chapter with the regulatory basis for each of them. McDowall has made it a lot easier for everyone by publishing this book. The amount of investigations that he has done in order to make system in the overwhelming craziness of the regulatory documents, is astonishing. -- Siri H. Segalstad, Segalstad Consulting AS, NorwayTable of ContentsPreface; Glossary, Abbreviations and Data Integrity Terms;How to Use This Book and an Introduction to Data Integrity; How Did We Get Here?; The Regulators' Responses; What Is Data Governance?; A Data Integrity Model; Roles and Responsibilities in a Data Governance Programme; Data Integrity Policies, Procedures and Training; Establishing and Maintaining an Open Culture for Data Integrity; An Analytical Data Life Cycle; Assessment and Remediation of Laboratory Processes and Systems; Data Integrity and Paper Records; Blank Forms and Instrument Log Books; The Hybrid System Problem; Get Rid of Paper: Why Electronic Processes are Better for Data Integrity; Data Integrity Centric Analytical Instrument Qualification and Computerised System Validation; Validating Analytical Procedures; Performing an Analysis; Second Person Review; Record Retention; Quality Metrics for Data Integrity; Raising Data Integrity Concerns; Quality Assurance Oversight for Data Integrity; How to Conduct a Data Integrity Investigation; Data Integrity and Outsourcing; Data Integrity Audit Aide Memoire; Subject Index
£118.75
De Gruyter Nano-Safety: What We Need to Know to Protect Workers
Book SynopsisNanotechnology safety is the practice of handling engineered nanomaterials in production and manufacturing. Good practice consists of understanding and interpreting Material Safety Data Sheets, behaving safely when working with yet unknown nanomaterials, understanding health effects, and proactively creating safety measures against potential hazards. This book addresses nanotechnology risk management.
£70.77
De Gruyter Food Science and Technology: Fundamentals and Innovation
Book SynopsisFood Science and Technology: Fundamentals and Innovation presents the aspects of microbiology, chemistry, nutrition, and process engineering required for the successful selection, preservation, processing, packaging, and distribution of quality food. It is a valuable resource for researchers and students in food science & technology and food industry professionals and entrepreneurs. There are two new chapters in the 2nd Ed. COVID-19 and food supply chain as well as climate-smart food science.
£86.40
Amsterdam University Press The Laboratory Revolution and the Creation of the
Book SynopsisThe modern research university originated in Europe in the second half of the nineteenth century, largely due to the creation and expansion of the teaching and research laboratory. The universities and the sciences underwent a laboratory revolution that fundamentally changed the nature of both. This revolutionary development began in chemistry, where Justus Liebig is credited with systematically employing his students in his ongoing research during the 1830s. Later, this development spread to other fields, including the social sciences and the humanities. The consequences for the universities were colossal. The expansion of the laboratories demanded extensive new building programs, reshaping the outlook of the university. The social structure of the university also diversified because of this laboratory expansion, while what it meant to be a scientist changed dramatically. This volume explores the spatial, social, and cultural dimensions of the rise of the modern research laboratory within universities and their consequent reshaping.Table of ContentsList of Figures and Tables Preface 1. The Joint Emergence of the Teaching-Research Laboratory and the Modern University: An Introduction ( Klaas van Berkel and Ernst Homburg) PART I: THE LABORATORY REVOLUTION: ORIGINS AND IMPACT 2. Origins and Spread of the ‘Giessen Model’ in University Science (Alan J. Rocke) 3. The Laboratory Ethos, 1850-1900 (Frans van Lunteren) PART II: LABORATORY NETWORKS 4. Chemistry in Zürich, 1833-1930: Developing the Teaching-Research Laboratory in the Swiss Context (Peter J. Ramberg) 5. Island Kingdoms in the Making: The New Laboratories and the Fragmentation of Dutch Universities c. 1900 (Klaas van Berkel) 6. A Fertile Ecosystem: University Chemical Laboratories and their Suppliers in Fin-de-Siècle Paris (Pierre Laszlo) 7. Fighting for Modern Teaching and Research Laboratories in Norway: The Chemistry Laboratory in Political Dispute Around 1920 (Annette Lykknes) 8. Religion and the Laboratory Revolution: Towards a Physiological Laboratory at a Calvinist University in the Netherlands, 1880-1924 (Ab Flipse) PART III: LABORATORY VALUES 9. Aspects of the Social Organization of the Chemical Laboratory in Heidelberg and Imperial College, London (Peter Morris) 10. Of Growing Significance: The Support Staff in the Laboratories and Institutes of Utrecht University During the Interwar Period (Bas Nugteren) 11. A Revolution in Genetics at Gendered Experimental Venues in Cambridge and London, 1890-1930 (Ida H. Stamhuis) 12. Serialized Laboratories: Laboratory Journals and the Making of Modern Science and Scientific Publishing, 1840s-1950s (Dorien Daling) 13. Images of the Laboratory in the Popular Press (Geert Vanpaemel) Acknowledgements
£121.60
