Böcker av Brendan Cooper

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.

This concise pocket sized book provides an introduction to Depyrogenation tunnels and Sterile Barrier systems (Isolators) as used within the LifeSciences. It is the perfect introduction to engineers or those new to the industry who wish to gain a practical grasp of how Depyrogenation tunnels work, how development studies are performed and key points of validation. Isolator Barrier systems are also covered in the same fashion. An extensive glossary is also provided. (Page count 145)

Biotechnology brings together many fields of expertise including engineering, chemistry, microbiology to mention a few. This paperback book provides a overview of the key themes and requirements of Aseptic processing and sterile manufacturing. It is written in a simple and plain style and provides a practical approach under standing the technologies used within the industry.Chapter 1: FacilitiesChapter 2: Clean UtilitiesChapter 3: Sterile Manufacturing OperationsChapter 4: DepyrogenationChapter 5: Cleaning and DisinfectionChapter 6: Process DevelopmentChapter 7: Physical ProcessesChapter 8: Equipment ValidationChapter 9: Performance QualificationChapter 10: GMP BasicsChapter 11: Data IntegrityGlossary

Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included: Introduction to Good Manufacturing Preparation for Audits Inspection of Quality Systems During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Drugs Inspection Guide, Computerised Systems Inspection Guide, Validation of Hardware and Software, Electronic Records and Signatures Electronic Records Verification Methods

This book provides a short introduction to Depyrogenation, Isolators and Aseptic Filling. The information is presented in simple language in order to make the material accessible and readable. It provides a concise and compact resource for Engineers and Scientists working within Biotechnology. While there a many book titles, guidance standards and reference books, there format does not allow for logical or practical reading. This book introduces key concepts in Aseptic processing and aims to provide the reader with knowledge that can be applied in industry. Perfect for those new to Aseptic Processing and wish to gain an aptitude in Depyrogenation and Aseptic Processing.Content includes: Introduction to Depyrogenation Tunnels, Isolators and Aspetic Filling, Equipment Validation, Performance Qualification, Critical Utilities, Facilities and Container Closure. A glossary is also provided for quick reference. Page Count 170 (Paperback 6"x 9")

In discussions of American poetry since World War II, the work of John Berryman has become increasingly neglected and marginalized. Critics have overwhelmingly chosen to favour the notion that he is an academic, ¿establishment¿ poet whose career can comfortably be described as a move from New Critical traditionalism towards self-absorbed confessionalism. This study shows how such a narrow understanding of Berryman¿s work is reflective of a broader critical inclination towards a codification of the literary canon as a duel between competing factions of a formalist, establishment ¿mainstream¿ and an experimentalist, countercultural ¿avant-garde¿. By examining the extent to which Berryman¿s poetry engages with the complex religiopolitical climate of Cold War American culture, this study exposes the inadequacy of the paradigm of mainstream traditionalism in relation to his work. In doing so, it opens up threads of comparative possibility between his work and that of poets ordinarily segregated from him by divisive conceptions of the literary canon. As such, this volume provides a reconsideration of Berryman¿s work that simultaneously asks broader questions about the nature of the American poetic canon and established definitions of ¿postmodern¿ poetry.