Quality Assurance in Research and Development


Book Description

Chapter 7: PROJECT CONSTRUCTION -- I. MATERIAL IDENTIFICATION AND CONTROL -- II. CONTROL OF SPECIAL PROCESSES -- III. INSPECTION -- IV. HANDLING, STORAGE, AND SHIPPING -- V. NONCONFORMING MATERIALS, PARTS, OR COMPONENTS -- APPENDIX: AN ANALYSIS OF CORRECTIVE ACTION REPORTS GENERATED DURING A 3-YEAR PERIOD -- REFERENCES -- Chapter 8: CONTROL OFMEASURING AND TEST EQUIPMENT -- I. THE NEED FOR FORMAL CONTROL -- II. TRACEABILITY -- A. Definition of Traceability -- B. Purposes and Uses of Traceability -- C. Measurement Traceability and Standards Traceability -- D. The Question Posed to NBS -- E. NBS Advice on Traceability -- III. PROGRAM DESCRIPTION -- IV. SCOPE -- V. QUALITY LEVELS -- VI. CENTRALIZED CONTROL -- VII. CALIBRATION PROCEDURES -- IX. EVALUATION OF CALIBRATION SUPPLIERS -- REFERENCES -- Chapter 9: TEST CONTROL -- I. TEST PLAN -- II. TEST PROCEDURES -- III . DOCUMENTATION AND REVIEW OF RESULTS -- REFERENCES -- Chapter 10: SOFTWARE -- I. BACKGROUND -- II. THE SOFTWARE QUALITY ASSURANCE PROGRAM -- A. Planning -- B. Software Quality Levels and QA Plans -- C. Software Development Process -- D. Evaluation -- REFERENCES -- Chapter 11: RECORDS AND REPORTING -- I. PROJECT RECORDS -- II. REPORTS -- III. TRACEABILITY -- IV. RETENTION -- REFERENCES -- Chapter 12: AUDITING THE PROGRAM -- I. GENERAL AUDITING CONSIDERATIONS -- II. PROJECTS -- A. Specified QA -- B. Standard Laboratory Practice -- III. SYSTEM AUDITS -- IV. SUPPLIER AUDITS -- REFERENCES -- INDEX













Management


Book Description




Management of Research & Development in the New Millennium


Book Description

Contributed papers presented earlier at International Conference on Management of Research and Development at Delhi, India on January 10-11, 2003.




A Practical Guide to Quality Management in Clinical Trial Research


Book Description

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co







Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection


Book Description

The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.




Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies


Book Description

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.