Parenteral Technology Manual

Michael J. Groves

Self-Help

Interpharm Press

Drug, device and diagnostic manufacturing: The ultimate resource handbook

DeSain, Carol

Drug regulation in African countries

Chidomere, Evans C

Designed to enable readers  to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.

Glp Quality Audit Manual

Medical Books

ANDERSON

Allied Health Professions

This sensible text on computer systems validation examines the regulatory and practical issues of computer validation from a global perspective and provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.

Good Computer Validation Practices: Common Sense Implementation

Science & Math

Stokes, Teri

Branning, Ronald C.

Chapman, Kenneth G.

Hambloch, Heinrich

Trill, Anthony J.

Mathematics

Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products - particularly in the medical device and equipment manufacturing industries. From high-level strategies and mechanics to detailed flow charts, tables, and sample forms, the text helps assure that all requisite phases of development and testing have been considered and implemented as readers develop a complete, integrated, cohesive, and interrelated software quality assurance program. Readers will learn how to design, implement, and manage the software development effort, as well as how to audit the program.

Software development and quality assurance for the healthcare manufacturing industries

Mallory, Steven R

Building blocks: Biotechnology reagents and consumables (The Interpharm biotech 2000 series)

Hochfeld, William L.

Biological Sciences

Validation of Computerized Analytical Systems

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

Computers & Technology

Huber, Ludwig

Programming

How to prepare for an FDA inspection (GMP training series)

Cutter, Michael

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications.With the tools this book provides, you'll learn how to:Ensure that your DMB system is in compliance with federal regulationsBuild a strategic data management and databsing planTrack and record CRFsDeal with problem data, adverse event data, and legacy dataManage and store lab dataIdentify and manage discrepanciesEnsure quality control over reportsChoose a CDM system that is right for your companyCreate and implement a system validation plan and processSet up and enforce data collection standardsDevelop test plans and change control systemsThis book is your guide to finding the most successful and practical options for effective clinical data management.

Practical Guide To Clinical Data Management

Prokscha, Susanne

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