The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities

The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers). Pharmaceutical facilities have particular needs for their production requirements. Stringent regulations are set by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) (in the UK) and the Food and Drugs Administration (FDA) in the US. This creates special problems of quality when it comes to the commissioning, validation and hand-over of the building, as it appears to be at odds with the rather less demanding quality systems that are normally accepted in the construction sector. The aim of the research is to model an acceptable process for incorporating these stringent validation requirements into the design, procurement and construction processes. There is little or no specific academic literature on the subject, though the trades and professional press (particularly in the USA) provide some normative comment on the problem area. The main academic grounding of the research is in Systems Theory and empirical data is being collecting using a multiple case study approach. Research data was collected from a number of pharmaceutical facility construction case studies and was used to test and inform a best practice model of facility validation. The qualitative methods of participant and direct observation were used as the main information gathering tools. The paper reports on the regulatory expectations that influence the construction of projects of this type and the impact on the best practice model of validation

Monitoring and Assessing the Use of External Quality Review Organizations to Improve Services for Young Children: A Toolkit for State Medicaid Agencies

Assesses the extent to which states use external quality review organizations in studying the quality of preventive and developmental services for young children enrolled in Medicaid, and provides guidance on determining their scope of work

Quality model for semantic IS standards

Semantic IS (Information Systems) standards are essential for achieving\ud interoperability between organizations. However a recent survey suggests that\ud not the full benefits of standards are achieved, due to the quality issues. This\ud paper presents a quality model for semantic IS standards, that should support\ud standards development organizations in assessing the quality of their\ud standards. Although intended for semantic IS standards the potential use of\ud this quality model is much broader and might be applicable to all kind of\ud standards

How Well Do Ontario Library Web Sites Meet New Accessibility Requirements?

New changes to Ontario law will require library web sites to comply with the Web Content Accessibility Guidelines, version 2.0 (WCAG 2.0). This study evaluates 64 Ontario university, college, and public library web sites to see how well they comply with WCAG 2.0 guidelines at present. An average of 14.75 accessibility problems were found per web page. The most common problems included invalid html, poor color contrast, incorrect form controls and labels, missing alt text, bad link text, improper use of headings, using html to format pages, using absolute units of measure, and issues with tables and embedded objects

Staying in School: Arts Education and New York City High School Graduation Rates

Explores links between arts education -- certified teachers, dedicated and equipped arts classrooms, partnerships, field trips -- and high school graduation rates in New York City public schools. Calls for arts instruction for at-risk students

Biodiversity Offset Program Design and Implementation

Biodiversity offsets are applied in many countries to compensate for impacts on the environment, but research on regulatory frameworks and implementation enabling effective offsets is lacking. This paper reviews research on biodiversity offsets, providing a framework for the analysis of program design (no net loss goal, uncertainty and ratios, equivalence and accounting, site selection, landscape-scale mitigation planning, timing) and implementation (compliance, adherence to the mitigation hierarchy, leakage and trade-offs, oversight, transparency and monitoring). Some more challenging aspects concern the proper metrics and accounting allowing for program evaluation, as well as the consideration of trade-offs when regulations focus only on the biodiversity aspect of ecosystems. Results can be used to assess offsets anywhere and support the creation of programs that balance development and conservation.TU Berlin, Open-Access-Mittel – 201

Evaluation of the Iowa Department of Transportation's Compensatory Wetland Mitgation Program, August 30, 2004

The purpose of this investigation was to evaluate the Compensatory Wetland Mitigation Program at the Iowa Department of Transportation (DOT) in terms of regulatory compliance. Specific objectives included: 1) Determining if study sites meet the definition of a jurisdictional wetland. 2) Determining the degree of compliance with requirements specified in Clean Water Act Section 404 permits. A total of 24 study sites, in four age classes were randomly selected from over 80 sites currently managed by the Iowa DOT. Wetland boundaries were delineated in the field and mitigation compliance was determined by comparing the delineated wetland acreage at each study site to the total wetland acreage requirements specified in individual CWA Section 404 permits. Of the 24 sites evaluated in this study, 58 percent meet or exceed Section 404 permit requirements. Net gain ranged from 0.19 acre to 27.2 acres. Net loss ranged from 0.2 acre to 14.6 acres. The Denver Bypass 1 site was the worst performer, with zero acres of wetland present on the site and the Akron Wetland Mitigation Site was the best performer with slightly more than 27 acres over the permit requirement. Five of the 10 under-performing sites are more than five years post construction, two are five years post construction, one is three years post construction and the remaining two are one year post construction. Of the sites that meet or exceed permit requirements, approximately 93 percent are five years or less post construction and approximately 43 percent are only one year old. Only one of the 14 successful sites is more than five years old. Using Section 404 permit acreage requirements as the criteria for measuring success, 58 percent of the wetland mitigation sites investigated as part of this study are successful. Using net gain/loss as the measure of success, the Compensatory Wetland Mitigation Program has been successful in creating/restoring nearly 44 acres of wetland over what was required by permits

Iowa Department for the Blind Performance Report, FY 2006

Agency Performance Repor