Full-time equivalent

Operations The QRA team will need specific data on how the system is actually operated. For example, are the bypass valves normally left open to increase throughput, what happens when the high level alarm sounds, or do operators bypass interlocks to continue production Human actions/errors are usually dominant contributors to the real-world risks, and truthful data on actual process operations are vital to credible QRA results. Expect to commit one full-time equivalent for the life of the project. 

Finally, the assessment should identify the existing PSM and ESH resources, both manpower and equipment. Manpower estimates should include full-time staff and the full-time-equivalent of the part-time contributions made by other staff You will need to probe for this information from part-time staff Do not ask simply for the percentage of time they spend on PSM or ESH issues, as it is likely to be a wildly... 

The business of CROs is usually done through a pay for service arrangement. Contrary to manufacturing companies, invoicing of CROs is not based on unit product price, but on full-time equivalents (FTEs), that is, the cost of a scientist working one year on a given customer assignment. For further details, see Sections 12.5 and 12.6. 

A volume priced approach, either bottom-up or top-down, is used for fine chemicals produced on an industrial scale a time-based one is used for those produced on a small scale, or for process research. The most frequently used unit for the former is /kg, respectively FTE (full-time equivalent) for the latter. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

Scaffold development cycles (often cited at six months per core for a 4-5-step linear solid phase route) are dramatically shortened. Eight novel production-ready cores were constructed by one full-time equivalent over a 12-month period in this laboratory. 

Full time equivalents (location-specific number of operators needed to staff one line if operated 24 hours a day 7 days a week)... 

A full-time equivalent (FTE) is a value used to measure the actual or budgeted work hours in an organization. One FTE is equal to 2080 hours per year (or 40 hours per week,... 

The first step in calculating the cost of analysis in the pharmaceutical industry is to determine the yearly cost of the analyst. This cost is referred to as a full-time equivalent (FTE). A typical FTE calculation is shown in Figure 3.5. The cost per year can be estimated as an annual cost of about 250,000, which would include factors for... 

Figure 3.5 A calculation of the costs associated with a full-time equivalent (FTE) analyst. (Courtesy of Milestone Development Services, Newtown, Pa., USA.)...

Like other early stage R D alliances, a large fraction of total pre-commercial payments from pharma licensee to biotech licensor in CC alliances comes in the form of R D reimbursement. Such reimbursement is usually negotiated as a minimum annual payment per year (R D/yr), either on a fixed dollar basis or as a function of the number of biotech full-time equivalent scientists (FTEs) expected to conduct the alliance program. In addition, R D reimbursement is usually negotiated for an expected number of years (R D term), although often it is possible for the licensee to cancel R D reimbursement prior to the completion of the R D term. 

The total full-time equivalent staff working in CDER is just under 2000. The number of FDA staff has increased in recent years as a result of the PDUFA of 1992 and the renewal of PDUFA in the FDA Modernization Act of 1997. On average, each of the five ODEs have about 125-135 employees. Because there are essentially three divisions per office, the average staff in a particular division is about 40-45, including clerical, secretarial, and project management support. Updates of these organizational charts may be found on the internet at http // www.fda.gov/cder/cderorg.htm. 

The BHPr model provides estimates of future headcounts of pharmacists—dearly a shortcoming in the sense that neither men nor women pharmacists contribute, on average, a single full-time equivalent (PTE) per person. Therefore, an important next step in more accurately predicting the size and character of the future pharmacy workforce is to overlay what is known about past and current work patterns of pharmacists on the BHPr model. 

Table 25.3 Headcounts Versus Estimated Full-Time Equivalents (FTEs)...

Elimination of the need to update the Lab Book for chromatographie analysis. This is a quick win that is estimated to save about 0.3 to 2.6 FTE (Full Time Equivalents or person years). This is independent of implementing eleetronic signatures in the CDS. 

Various methods can be used for the calculation of internal costs, two of which have been published widely the Hoechst Marion Roussel Model (Hill and Hubbard, 1996) and the MSD BARDS Model (Papazian and Wise, 1995). A reliable and reproducible method must include the calculation of the cost of a full-time equivalent (Fib) employee at... 

Among RPICs there is a pool of 531 SPIs Pharmacists account for 35% of the SPIs, nurses 58%, and others 7% (Fig. 2). Within nonregional centers there are an additional 58 full-time equivalent pharmacist staff positions. Therefore, it is apparent that there is a career opportunity for pharmacists within this discipline, albeit a somewhat limited one. Nurses dominate RPIC staffing. During the formative years of poison center evolution,... 

Specialist in Poison Information full-time equivalent positions (FTEs) must be filled by Certified Specialists in Poison Information. For certified poison center systems, at least 50% of Specialists in Poison Information FTEs at each site must be Certified Specialists in Poison Information. 

Finally, the appeal of sourcing in China is based on China s low cost stmcture for all phases of drug development. The costs of conducting clinical trials in China is approximately 20 to 25% of those in the United States. A full-time equivalent (FTE) in China costs about US 40,000 to US 100,000 per year in the Shanghai area and even less in inland regions such as Chengdu. In the United States, an FTE costs upward of US 200,000 to US 250,000 per year. In addition to low overhead costs, the hourly wages in China are about 25% those of Western countries. 

FIGURE 28.3 (See color insert following page 40). Process development/optimization via full-time equivalents (IP, intellectual property). 

FIGURE 28.4 Global coordination (FTEs, full-time equivalents). 

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