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Regulatory Compliance (regulatory + compliance)
Selected AbstractsGreen Clubs and Voluntary Governance: ISO 14001 and Firms' Regulatory ComplianceAMERICAN JOURNAL OF POLITICAL SCIENCE, Issue 2 2005Matthew Potoski Voluntary programs have become widespread tools for governments and nongovernmental actors looking to improve industry's environmental and regulatory performance. Voluntary programs can be conceptualized as club goods that provide nonrival but potentially excludable benefits to members. For firms, the value of joining a green club over taking the same actions unilaterally is to appropriate the club's positive brand reputation. Our analysis of about 3,700 U.S. facilities indicates that joining ISO 14001, an important nongovernmental voluntary program, improves facilities' compliance with government regulations. We conjecture that ISO 14001 is effective because its broad positive standing with external audiences provides a reputational benefit that helps induce facilities to take costly progressive environmental action they would not take unilaterally. [source] IMPLEMENTING BEST PRACTICE REGULATION IN A DYNAMIC MARKETPLACE: CONSULTATION AND ACCOUNTABILITYECONOMIC PAPERS: A JOURNAL OF APPLIED ECONOMICS AND POLICY, Issue S1 2008RIC SIMES The practice of financial regulation in Australia has drifted away from the lighted-handed principles articulated in the Wallis Report. The burden of regulatory compliance has steadily grown. The inconsistency between regulatory principle and practice is explained as the result of perverse incentives facing regulators, an absence of effective consultation with industry regarding the cost burden of regulation, and a failure to properly assess the social benefits and costs of regulatory intervention. The paper argues for the creation of a Bureau of Financial Sector Regulation to improve the accountability of regulators and publish independent social cost,benefit analyses of financial regulation. The paper also calls for a further inquiry into Australia's financial system ten years on from the Wallis Inquiry. [source] A practical way to manage IT costsJOURNAL OF CORPORATE ACCOUNTING & FINANCE, Issue 5 2005Timothy Iijima Information technology (IT) consumes 4 percent of a typical large company's revenue. And these days, companies are under tremendous pressure to manage IT costs,while also handling new concerns about disaster recovery, security, and regulatory compliance. That's tough, concedes the author of this article. But he offers a tested, practical strategy to get the job done. © 2005 Wiley Periodicals, Inc. [source] Biology and establishment of mountain shrubs on mining disturbances in the Rocky Mountains, USALAND DEGRADATION AND DEVELOPMENT, Issue 5 2003M. W. Paschke Abstract The Rocky Mountains of the western United States contain many economically important natural resources. Increasing development of these resources has lead to land degradation, which often requires restoration efforts. A common type of disturbance in this region is mineral extraction and these activities often occur in zones of vegetation dominated by shrubs. These mined lands have proven to be particularly challenging to restore to native shrub cover. Mountain shrubland species such as big sagebrush (Artemisia tridentata), antelope bitterbrush (Purshia tridentata), Saskatoon serviceberry (Amelanchier alnifolia), black chokecherry (Prunus virginiana), mountain mahogany (Cercocarpus montanus), and snowberry (Symphoricarpos sp.) are crucial species for wildlife in this region due to the seasonal dependence of many wildlife species on the mountain shrubland zones. The development of successful restoration techniques for these key shrub species is therefore important for the continued and sustainable utilization of natural resources in the Rocky Mountains. The purpose of this literature review is to provide a reference to land managers working on woody plant establishment on mining disturbances in mountain shrublands in the Rocky Mountains. This review covers the biology, ecology, and propagation of six shrub species that are of primary importance for meeting regulatory compliance in this region. Based upon this survey of the published literature, we conclude that successful establishment of these species has most often involved: (1) utilization of local shrub ecotypes, varieties or subspecies in reclamation efforts, (2) protection from browsing during the establishment phase, (3) strategies for avoiding herbaceous competition, and (4) providing a source of mutualistic soil organisms. Additional specific recommendations for each of these species are discussed. Copyright © 2003 John Wiley & Sons, Ltd. [source] Meeting the challenges of implementing good laboratory practices compliance in a university settingQUALITY ASSURANCE JOURNAL, Issue 1 2002Sandra Hancock Abstract The number of university laboratories participating in good laboratory practices (GLP) studies is on the rise, as evidenced by the increase in university personnel that have joined the Society of Quality Assurance (SQA) during the past decade. However, the road to GLP compliance in the university setting has significant challenges. To evaluate how universities have implemented and managed GLP studies, a survey was conducted of SQA members with a university address. The results are described in this article. At Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM), we have been participating in GLP studies since 1989. Studies are conducted by research or clinical faculty members, with quality assurance (QA) provided by the College Quality Assurance Unit. Since the inception of our GLP Program, VMRCVM has made significant progress toward meeting the challenges of regulatory compliance. Copyright © 2002 John Wiley & Sons, Ltd. [source] Biomanufacturing process analytical technology (PAT) application for downstream processing: Using dissolved oxygen as an indicator of product quality for a protein refolding reactionBIOTECHNOLOGY & BIOENGINEERING, Issue 2 2009Shelly A. Pizarro Abstract Process analytical technology (PAT) is an initiative from the US FDA combining analytical and statistical tools to improve manufacturing operations and ensure regulatory compliance. This work describes the use of a continuous monitoring system for a protein refolding reaction to provide consistency in product quality and process performance across batches. A small-scale bioreactor (3,L) is used to understand the impact of aeration for refolding recombinant human vascular endothelial growth factor (rhVEGF) in a reducing environment. A reverse-phase HPLC assay is used to assess product quality. The goal in understanding the oxygen needs of the reaction and its impact to quality, is to make a product that is efficiently refolded to its native and active form with minimum oxidative degradation from batch to batch. Because this refolding process is heavily dependent on oxygen, the % dissolved oxygen (DO) profile is explored as a PAT tool to regulate process performance at commercial manufacturing scale. A dynamic gassing out approach using constant mass transfer (kLa) is used for scale-up of the aeration parameters to manufacturing scale tanks (2,000,L, 15,000,L). The resulting DO profiles of the refolding reaction show similar trends across scales and these are analyzed using rpHPLC. The desired product quality attributes are then achieved through alternating air and nitrogen sparging triggered by changes in the monitored DO profile. This approach mitigates the impact of differences in equipment or feedstock components between runs, and is directly inline with the key goal of PAT to "actively manage process variability using a knowledge-based approach." Biotechnol. Bioeng. 2009; 104: 340,351 © 2009 Wiley Periodicals, Inc. [source] Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology productsBIOTECHNOLOGY & BIOENGINEERING, Issue 1 2009Daniel M. Strauss Abstract The mammalian cell-lines used to produce biopharmaceutical products are known to produce endogenous retrovirus-like particles and have the potential to foster adventitious viruses as well. To ensure product safety and regulatory compliance, recovery processes must be capable of removing or inactivating any viral impurities or contaminants which may be present. Anion exchange chromatography (AEX) is a common process in the recovery of monoclonal antibody products and has been shown to be effective for viral removal. To further characterize the robustness of viral clearance by AEX with respect to process variations, we have investigated the ability of an AEX process to remove three model viruses using various combinations of mAb products, feedstock conductivities and compositions, equilibration buffers, and pooling criteria. Our data indicate that AEX provides complete or near-complete removal of all three model viruses over a wide range of process conditions, including those typically used in manufacturing processes. Furthermore, this process provides effective viral clearance for different mAb products, using a variety of feedstocks, equilibration buffers, and different pooling criteria. Viral clearance is observed to decrease when feedstocks with sufficiently high conductivities are used, and the limit at which the decrease occurs is dependent on the salt composition of the feedstock. These data illustrate the robust nature of the AEX recovery process for removal of viruses, and they indicate that proper design of AEX processes can ensure viral safety of mAb products. Biotechnol. Bioeng. 2009;102: 168,175. © 2008 Wiley Periodicals, Inc. [source] Measuring corporate environmental performance: the trade-offs of sustainability ratingsBUSINESS STRATEGY AND THE ENVIRONMENT, Issue 4 2010Magali Delmas Abstract Socially responsible investing (SRI) represents an investment process that reflects environmental and social preferences. The financial industry is in a unique position to move corporations towards corporate sustainability. However, there is often little transparency regarding the metrics used to evaluate corporate social and environmental performance and the trade-offs involved in the evaluation. In this paper we discuss the various trade-offs of sustainability screening methodologies. We show that the rating of companies varies significantly according to whether the screening is based on toxic releases and regulatory compliance or on the quality of environmental policy and disclosure. We base our analysis on the evaluation of the performance of 15 firms in the chemical sector. The analysis indicates that firms that have the most advanced reporting and environmental management practices tend also to have higher levels of toxic releases and lower environmental compliance. We provide methodological recommendations to help stakeholders evaluate corporate environmental performance. Copyright © 2010 John Wiley & Sons, Ltd and ERP Environment. [source] Stakeholders and environmental management practices: an institutional frameworkBUSINESS STRATEGY AND THE ENVIRONMENT, Issue 4 2004Magali Delmas Despite burgeoning research on companies' environmental strategies and environmental management practices, it remains unclear why some firms adopt environmental management practices beyond regulatory compliance. This paper leverages institutional theory by proposing that stakeholders , including governments, regulators, customers, competitors, community and environmental interest groups, and industry associations , impose coercive and normative pressures on firms. However, the way in which managers perceive and act upon these pressures at the plant level depends upon plant- and parent-company-specific factors, including their track record of environmental performance, the competitive position of the parent company and the organizational structure of the plant. Beyond providing a framework of how institutional pressures influence plants' environmental management practices, various measures are proposed to quantify institutional pressures, key plant-level and parent-company-level characteristics and plant-level environmental management practices. Copyright © 2004 John Wiley & Sons, Ltd and ERP Environment. [source] | |||||||||||||