Design individual

The HASP should describe how potential health and safety hazards at the work site are located, identified, and measured. A written schedule including inspections and walk-throughs conducted by designated individuals should be specified. 

Ideally, the staffers you recruit to conduct a PSM assessment should be a dedicated team that is, the same team assesses each facility or organization, using the same method and format. This may not be practical in many companies, in which qualified staff are often overcommitted a workable alternative is a "revolving door" approach, under which assessment team composition varies according to designated individuals availability. 

In some organizations, designated individuals have specific responsibility for eliciting detailed information from operational staff on the immediate and underlying causes of incidents. An example is the Human Performance Evaluation System (HPES) developed for the nuclear industry, which is described in Bishop and Larhette (1988). These coordinators provide a certain level of guaranteed irrununity from sanctions which allows individuals to be frank about the contributory causes that they may not be willing to discuss in an open forum. As discussed earlier, the need for this approach is a consequence of the fact that in many organizations a blame culture exists which is likely to inhibit a free flow of information about the causes of accidents. 

The regulatory authorities must be informed of any planned recall actions (see Chapter 12). Procedures are also required for emergency un-blinding of materials undergoing clinical trial. The responsibility for complaints and the initiation of product recalls should be assigned to designated individuals. 

Design individualized drug therapy treatment plans for patients with (1) sinus bradycardia (2) AV nodal blockade (3) AF (4) PSVT (5) VPDs (6) VT (including torsades de pointes) and (7) VF. 

Improvement Item Development of a recovery checklist may be beneficial for future incidents to address issues such as CIS debriefings, vehicle recovery, and temporary department facilities. Designated individual should be identified to coordinate donations and volunteers. 

At minimum, chemical industrial facilities should identify a single, designated individual responsible for overall security, even if other security roles and responsibilities will likely be dispersed throughout the organization. 

Electrons do not fill orbitals one at a time. Nor do electrons have properties that designate individual electrons as first, second, third, fourth, etc. 

The laboratoiy should have a documented Quality Assurance Programme, carried out by designated individual(s), to assure that the activities perfonned are in compliance with the principles of GLP. The QA personnel must conduct inspections to determine if all of the laboratory activities are conducted in accordance with the principals of GLP and defined SOPs. These personnel... 

Designated individuals as members of the QA team directly responsible to the management... 

The system uses independent filter wheels (Fig. 2) with up to 16 different filters for excitation (270-550 nm) and emission (310-590 nm) and performs measurements in steps of 20 nm, which was found to be most suitable without any loss of information. The number of measurements for each filter position can be individually chosen. Adapted to the different industrial processes, properties and steps of filters can be designed individually to cover most of the information potential. In addition it is possible to monitor single-wavelength pairs continuously. A high measuring frequency (10/s) enables in situ mixing time experiments for bioreactor characterization [49]. The singlewavelength pairs could be selected dependent of the available or suitable fluorophores. 

The calibration date, the calibrator, and the next calibration date shall be recorded and displayed, or records containing such information shall be readily available for each piece of equipment requiring calibration. A designated individual(s) shall maintain a record of calibration dates and of the individual performing each calibration. 

The term carbene is used here as a generic designation individual carbenes are named as substituted methylenes. For reviews of carbene chemistry, see (a) D. Bethell, Adeem. Phys. Org. Chem., 7, 153 (1969) (b) G. L. Closs, Top. Stereochem., 3, 193 (1968) (c) W. Kirmse, Carbene Chemistry, 2nd ed., Academic Press, New York, 1971 (d) J. Hine, Divalent Carbon, Ronald Press, New York, 1964 (e) M. Jones and R. A. Moss, Eds., Carbenes, Wiley, New York, 1973, Vol. 1. 

Figure 5. An extracted fraction of a sample of sand spiked with two mixtures EPA surrogate spike and phenol spike mixtures. Retention times designate individual components selected to evaluate the repeatability measure of the recovery data.

The validation protocol is a detailed plan for conducting a validation study. It is drafted by the individual or task group responsible for the project, reviewed for content and completeness following the firm s protocol review procedure, and approved by designated individuals. It describes the responsibilities of each individual or unit involved in the project. 

One reason for interlaboratory differences in the reproducibility of immunostaining results is the use of microwave ovens with significant differences in age, power, construction, and design. Individual laboratories should optimize wattages and duration of heating as well as durations of each of the steps mentioned above some of them will need to be determined by trial and error. 

The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment, and personnel changes to determine if and when revalidation is warranted. 

The designated individual(s) responsible for the quality management system must have... 

All hardware and/or software changes must be made by a designated individual(s)... 

The name of the calibrator, calibration date, and the date of the next calibration must be recorded. This information must be maintained by a designated individual(s) and must be readily retrievable for each piece of hardware requiring calibration. 

There must be a written procedure for the acceptance/rejection of computer hardware/ software that is included in the finished device, and a designated individual(s) must cany out this process. 

Keep the FDA informed. Once a file has been opened through a meeting request, inquiry, or submission, the project is assigned to an FDA contact. That designated individual can serve as a conduit to appropriate directors, committees, review boards, and divisions. 

The challenge now is to design individual POM cluster molecules that can interact both with each other and with the macroscale (as shown in Figure 2.12), in a desired fashion in response to inputs and environmental effects, so that a functioning molecular system is really constructed. 

Design Individually tailored for each reaction Modular often can be ordered from catalogs... 

Studies can be conducted with a group comparison or with cross-over design. Individual parameters can be averaged over predefined time periods but it may not always be possible to predict the time of drug-induced effects. Also, in freely moving animals, drug-induced changes may not be continuous but there may be... 

In a reduced design individuals at the extremes of renal function (normal and severely impaired individuals) are studied. The aim of such a study is to confirm that the pharmacokinetics is not altered to a clinically relevant extent. A prerequisite to this approach is a good reason to believe that renal impairment does not affect the PK to a degree sufficient to warrant dosage adjustment. 

Figure 7.1 The design of a cohort study and its relationship with case-control study designs. Individuals who died during follow-up in the shaded area are eligible for inclusion in a case-control study including incident cases between t and t2- The controls in the case-control study are individuals who did not have the disease of interest at the time of involvement. Arrows indicate end of follow-up, either because of (a) loss to follow-up, (b) mortality due to cause of interest, or (c) other causes of death. The risk ratio, or relative risk (RR) = ( died cause of interest in exposed/E person years)/( died cause of interest controls/E person years)...

In the event of an alarm from the [computer system] the operators are to acknowledge the alarm, call or contact a designated individual. 

If N becomes sufficiently large k may be treated as a continuous function and used to designate individual species. The lump C(r) can then be expressed in the integral form... 

---