MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'The Quality Assurance Journal' source. Tue, 16 Mar 2010 17:27:24 +0100 http://www.medworm.com/index.php?rid=3234661&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.449 This article focuses on preparation of a Clinical Investigator site, immediately prior to FDA inspection. This process can be driven by either the Sponsor or the Clinical Investigator site, but ideally it is a combined approach involving both parties, as well as the Contract Research Organization (CRO) if one is used. This 'last minute' preparation task can arise at any time whereby there is some prior FDA notice of an impending inspection, which often occurs after a clinical trial has been completed, the marketing application has been submitted, the research site is notified directly and/or the Sponsor is asked for additional information concerning specific sites. The author believes that this is not the time for a Quality Assurance (QA) audit but rather a management and organizational ta... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3234661 Wed, 03 Feb 2010 00:00:00 +0100 3234661 http://www.medworm.com/index.php?rid=2411804&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.441 The need for Quality standards in non-regulated research is a matter of considerable current debate. Whilst a number of such guidelines have been developed over recent years, their successful implementation remains a challenge to all. In order to assess whether research standards are indeed improving on the bench following the instigation of such a quality system, a question posed by both senior management and scientists alike, an independent compliance programme is required. However, given the lack of predicate rules, naivety to audit process and general sensitivity to external scrutiny within the scientific ranks, then work in this 'Grey Area' generates high exposure for the conventional GLP, GCP or GMP auditor. We have developed, tried, and tested a highly effective, novel audit model f... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=2411804 Fri, 15 May 2009 04:00:00 +0100 2411804 http://www.medworm.com/index.php?rid=2338530&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.442 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=2338530 Wed, 01 Apr 2009 04:00:00 +0100 2338530 http://www.medworm.com/index.php?rid=1474011&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.424 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=1474011 Tue, 01 Apr 2008 04:00:00 +0100 1474011 http://www.medworm.com/index.php?rid=606336&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.400 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=606336 Sun, 01 Apr 2007 04:00:00 +0100 606336 http://www.medworm.com/index.php?rid=366266&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.396 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366266 Tue, 16 Jan 2007 07:00:00 +0100 366266 http://www.medworm.com/index.php?rid=366265&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.397 The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 June 2006 to 31 August 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366265 Tue, 16 Jan 2007 07:00:00 +0100 366265 http://www.medworm.com/index.php?rid=366264&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.387 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366264 Tue, 16 Jan 2007 07:00:00 +0100 366264 http://www.medworm.com/index.php?rid=366263&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.393 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366263 Tue, 16 Jan 2007 07:00:00 +0100 366263 http://www.medworm.com/index.php?rid=366262&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.391 Ask almost anyone who has been involved in writing Standard Operating Procedures (SOPs) about how they learned to do it and chances are the answer will be that they just sat down and wrote their ideas, maybe using a standard format. Although process flows and flow charts have been an integral part of the computer world for as long as most care to remember, it has only been in the past decade or so that the concepts of process design and process flows have started to enter the realm of SOP development in the pharmaceutical industry. In this installment of the series, we will describe one process design approach to developing SOPs for a laboratory. Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366262 Tue, 16 Jan 2007 07:00:00 +0100 366262 http://www.medworm.com/index.php?rid=366261&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.394 Ethical decision-making in a major USA pharmaceutical company was studied. One prevailing model for investigating professional ethics has been to assume that the professional domain itself is morally neutral, and that individuals simply deploy their own personal, privately held values within their professions. Our research, however, indicates that the professional context - which we describe by means of the current concept 'communities of practice' - plays a significant role in guiding how these researchers and project managers express their beliefs about what is appropriate behavior in their own profession. We further discovered that it is quite possible to overlook the influence of a community of practice in shaping a moral perspective, owing to differences in the way testing instruments... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366261 Tue, 16 Jan 2007 07:00:00 +0100 366261 http://www.medworm.com/index.php?rid=366260&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.392 The intent of this study was to design, document and implement a Quality Management System (QMS) into a laboratory that incorporated both research and development (R&D) and routine analytical activities. In addition, it was necessary for the QMS to be easily and efficiently maintained to: (a) provide documented evidence that would validate the system's compliance with a certifiable standard, (b) fit the purpose of the laboratory, (c) accommodate prevailing government policies and standards, and (d) promote positive outcomes for the laboratory through documentation and verification of the procedures and methodologies implemented. Initially, a matrix was developed that documented the standards' requirements and the necessary steps to be made to meet those requirements. The matrix provided a ... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366260 Tue, 16 Jan 2007 07:00:00 +0100 366260 http://www.medworm.com/index.php?rid=366259&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.390 The Quality Assurance (QA) strategy for assessing Good Laboratory Practice (GLP) compliance at different testing facilities varies from focusing on study data verification to taking a quality system approach. As a best practice and to ensure overall compliance with GLP regulations, the Quality Assurance Unit (QAU) should perform three types of internal audits: study-specific, process-based, and system inspection. These internal audits serve as a tool to ascertain whether a GLP compliance program is functioning correctly. Information gathered from these audits can also be used to provide assistance during the evolution of a new GLP compliance program. As the GLP compliance program matures, internal audits can be a useful mechanism to help maintain compliance and promote continued improvemen... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366259 Tue, 16 Jan 2007 07:00:00 +0100 366259 http://www.medworm.com/index.php?rid=366258&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.388 A well-balanced maintenance program furnishes information and instructions to personnel involved in maintaining existing equipment, provides current information on the availability and location of maintenance materials, improves utilization of labor forces and increases equipment reliability. Planned and preventive maintenance procedures where components are serviced and changed when they approach the end of their useful lives can be augmented by suitable means, which continuously check vital machine functions. Quality Assurance can be seen as a management system that brings maintenance activities undertaken by all parties under control with the aim of preventing things from going wrong and costing time, effort and money to put them right. An attempt has been made to highlight the integrat... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366258 Tue, 16 Jan 2007 07:00:00 +0100 366258 http://www.medworm.com/index.php?rid=366256&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.389 There needs more clarity in ad hoc Good Laboratory Practice (GLP) certification conferred to test facilities of non-member economies. There is a similar kind of issue with the 'GLP status' of the test data generated by a test facility that has been conferred GLP certification by the country that is only a provisional adherent. In both cases, the objective of the Mutual Acceptance of Data (MAD) system will not be fulfilled if the answer is 'no'. Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366256 Tue, 16 Jan 2007 07:00:00 +0100 366256 http://www.medworm.com/index.php?rid=366254&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.395 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366254 Fri, 01 Dec 2006 07:00:00 +0100 366254 http://www.medworm.com/index.php?rid=230498&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.386 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230498 Wed, 11 Oct 2006 22:07:01 +0100 230498 http://www.medworm.com/index.php?rid=230497&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.382 The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 March 2006 to 31 May 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230497 Wed, 11 Oct 2006 22:07:01 +0100 230497 http://www.medworm.com/index.php?rid=230496&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.385 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230496 Wed, 11 Oct 2006 22:07:01 +0100 230496 http://www.medworm.com/index.php?rid=230495&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.380 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230495 Wed, 11 Oct 2006 22:07:01 +0100 230495 http://www.medworm.com/index.php?rid=230494&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.379 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230494 Wed, 11 Oct 2006 22:07:01 +0100 230494 http://www.medworm.com/index.php?rid=230493&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.378 This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel.Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since there is a logical structure to delivered information; thus, users can control the level of detail based on their need. (5) Reduced effort for upkeep of individual documents... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230493 Wed, 11 Oct 2006 22:07:01 +0100 230493 http://www.medworm.com/index.php?rid=230492&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.377 Maintaining company processes will afford optimum operation and enhance the company's quality management system. A vital part of maintaining processes is their periodic evaluation. An important part of the monitoring and evaluation process is the flow diagram. A detailed flow diagram is an important tool that affords ease in visualizing the total process and is an aid in locating problem areas. The evaluation of a process is broken down into 15 steps. These steps cover gathering pertinent information, such as problem symptoms from knowledgeable sources and carrying these through their route to potential problem areas to the problems, potential causes, and the root cause of the problem. Knowing the problems brings about the need to assess their impact on the process operation as well as wha... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230492 Wed, 11 Oct 2006 22:07:01 +0100 230492 http://www.medworm.com/index.php?rid=230491&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.383 With the complexity of today's studies, it has become increasingly critical that Study Directors understand all disciplines involved in studies under their responsibility. Every phase of a study directly impacts the outcome. If the Study Director does not have sufficient expertise to evaluate problems and issues in all areas as they occur, then study integrity is compromised. The physical location of the Study Director in a multi-site study is of less importance than the education, experience and expertise of that individual. The Study Director must be the single point of control and truly qualified to evaluate all the phases of the study, troubleshoot problems, draw appropriate conclusions, tie all aspects together and write the final report. Copyright © 2006 John Wiley & Sons, Ltd. (Sou... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230491 Wed, 11 Oct 2006 22:07:01 +0100 230491 http://www.medworm.com/index.php?rid=230490&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.376 Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. It describes and qualifies these activities as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9). Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230490 Wed, 11 Oct 2006 22:07:01 +0100 230490 http://www.medworm.com/index.php?rid=230489&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.384 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230489 Fri, 01 Sep 2006 06:00:00 +0100 230489 http://www.medworm.com/index.php?rid=208004&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.363 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=208004 Sat, 01 Apr 2006 07:00:00 +0100 208004