Response to Issues

National Competent Authorities are primarily responsible for managing responses to pharmacovigilance issues on their territory. However, the reference Member State is 

For urgent safety issues a Rapid Alert System has been established to ensure that the crisis is managed quickly and efficiently. The EudraNETnetwork is at the core of this response as it provides an efficient means of confidential data exchange between 

This system is also used where an urgent product recall is required because of safety issues arising from quality problems during manufacture, for example a labelling mix up or the contamination of a sterile product. The authorities must be advised immediately of any situations where such action is contemplated, while a report on the effectiveness of the recall should be furnished at the end of the process. 

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The next few years are likely to see considerable changes in the drug scene and in drug services, as agencies (and government departments) work out their responses to issues such as harm reduction, prescribing, and AIDS/HIV, particularly in the light of the recommendations of... 

A conventional response to issues of variability in bioassays is to construct Shewhart Control Charts based on the results achieved in repeat tests within a laboratory using a reference toxicant. This effectively describes the range of results typically found within the laboratory and hence can be used to define limits within which the laboratory normally expects to operate. However, there is a flaw in such internal quality control because the more variable a laboratory s reference toxicant test results are, the wider the limits of acceptability will be. Indeed, it can serve merely to reinforce high variability or bias. 

EPA. 1991b. Science Advisory Board s review of the Office of Research and Development draft document Response to issues and data submissions on the carcinogenicity of tetrachloroethylene (perchloroethylene) (February 1991). U.S. Environmental Protection Agency. EPA-SAB-EHC-91-013. 

After these standards were established, along with an appropriate test procedure, the California Legislature created a Motor Vehicle Pollution Control Board (MVPCB) and gave it the responsibility to issue certification to control devices meeting certain criteria of performance, durability, cost and ease of inspection. It also provided that, one year after certification of two or more devices, all new vehicles to be registered in the state would have to be equipped with such devices. 

In the multicompany environment, we have the additional requirement of coordination between organizations so that consistent communication, education, and responses to issues can be provided. 

Timely responses to issues say a lot about the culture. Once there is recognition of a safety or process safety deficit or concern and especially one of significance, there must be a timely evaluation, proposed solution, an action plan and timely updates. There is a silent signal - but well heard - in long delays and inaction [11]. 

Although ASTM specifies certain quaUty levels, there are a number of factors that contribute to other quaUty levels in the marketplace. At times, government regulations are more restrictive than ASTM specifications, especiaHy with respect to environmental issues. Secondly, competitive forces may encourage companies to provide fuel quaUty that is better than that defined by ASTM. Thirdly, ASTM specifications do not have the force of law, and certain companies may decide to exceed or not meet their recommended values. In response to this last factor, some states have adopted ASTM fuel quahty specifications as state regulations, thus forcing a minimum quaUty level in the field. 

Hazardous Waste Operations and Emergency Response. In response to an EPA mandate in SARA, Ha2ardous Waste Operations and Emergency Response (HAZWOPER) regulations were issued. These address emergency responders, training of those working at Superfund sites, and cleanup operations. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

Optimization should be viewed as a tool to aid in decision making. Its purpose is to aid in the selection of better values for the decisions that can be made by a person in solving a problem. To formulate an optimization problem, one must resolve three issues. First, one must have a representation of the artifact that can be used to determine how the artifac t performs in response to the decisions one makes. This representation may be a mathematical model or the artifact itself. Second, one must have a way to evaluate the performance—an objective function—which is used to compare alternative solutions. Third, one must have a method to search for the improvement. This section concentrates on the third issue, the methods one might use. The first two items are difficult ones, but discussing them at length is outside the scope of this sec tion. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

The prime vendor for the PRT shall perform lateral, torsional, and rotor response to unbalanee analyses of the eomplete rotor system and shall issue reports of these analyses to the Purehaser. 

As of this time, no one has solved the problem of the effect of asperities on a curved surface nor has anyone addressed the issue of crystalline facets. Needless to say, the problem of asperities on an irregular surface has not been addressed. However, Fuller and Tabor [118] have proposed a model that addresses the effects of variations of asperity size on adhesion for the case of planar surfaces. Assuming elastic response to the adhesion-induced stresses, they treated surface roughness as a random series of asperities having a Gaussian height distribution (f> z) and standard deviation o. Accordingly,... 

Does the SAHP provide for the individual responsible for authorizing eutting and welding operations to issue written permits granting sueh authorization [OSHA Referenee. 252(aX2)(iv)]... 

Nevertheless, as response data have accumulated and the nature of the porous deformation problems has crystallized, it has become apparent that the study of such solids has forced overt attention to issues such as lack of thermodynamic equilibrium, heterogeneous deformation, anisotrophic deformation, and inhomogeneous composition—all processes that are present in micromechanical effects in solid density samples but are submerged due to continuum approaches to mechanical deformation models. 

Provide those responsible for the preparation of subcontracts requirements to approve them prior to issue to the subcontractor. 

A trade association of chlorobenzene producers who seek to coordinate industry efforts regarding their product. CPA is concerned with scientific, environmental, and safety issues involving these chemicals in response to federal, state, and international regulator activities. 

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