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Standard Operating Procedures (SOPs) serve as the cornerstone of Good Manufacturing Practice (GMP) and quality systems within the pharmaceutical industry. Organizations generate numerous SOPs to uphold the quality and safety standards of their products and services. However, these documents often lack quality. Typically, SOPs are wordy, confusing, and complicated. Professionals tasked with writing SOPs usually possess extensive knowledge of their subject matter but often lack training in technical writing skills. As a result, the quality of SOPs suffers. "Best Practices for Writing Standard Operating Procedures (SOPs)" offers a comprehensive guide to enhance your SOP writing skills and improve the quality of these critical documents.
Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * An explanation of what standard operating procedures are and how they work * A selection of actual standard operating procedures and checklists This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.
Compiled by two experts in Reproductive Medicine, with contributions from internationally respected specialists, this innovative text lets the whole team in Reproductive Medicine get literally on the same page. Taking a cook-book approach to the operational procedures in the laboratory and in the clinic, it details what needs to be prepared in advance, what needs to be prepared earlier the same day, and what steps to take before, during, and after the procedure itself. This is an essential tool for ensuring all staff - whether experienced or starters - can be confident in their tasks and are in touch with what is expected of them and their colleagues.
The U.S. Department of State charged the Academies with the task of producing a protocol for development of standard operating procedures (SOPs) that would serve as a complement to the Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management and be included with the other materials in the 2010 toolkit. To accomplish this task, a committee with experience and knowledge in good chemical safety and security practices in academic and industrial laboratories with awareness of international standards and regulations was formed. The hope is that this toolkit expansion product will enhance the use of the previous reference book and the accompanying toolkit, especially in developing countries where safety resources are scarce and experience of operators and end-users may be limited.
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.