Project management personnel

Time allocated for completion of the works >- Nominated project management personnel, including health and safety responsibility >- Procedures for checking the competence of subcontractors... 

Although a single project manager may direct activities throughout a project life, he or she will normally be supported by a project team whose oomposition should reflect the type of project and the experience levels of both company and contractor personnel. The make up and size of the team may change over the life of a project to match the prevailing activity levels in each particular section of the project. 

The project manager (PM) is typically responsible for making sure that the necessary personnel are available for the project and that the reporting, scheduling, and budgetary obligations are met. 

This is important information that describes the site and provides workers, visitors, and other personnel with pertinent site information. In addition to studying job specifications, contracts, and talking with project management, the author(s) should develop a detailed operating history of the site. The history is useful when determining potential site hazards. The type of information that can typically be located includes ... 

Allocation of human resources With limited personnel, project managers often have different views than others have on how staff will be assigned. 

A small but diverse team of personnel is typically involved in the activities of the Project Identification and Definition Stage (refer to Figure 2.1). Representatives from groups such as process analytics, process control, project management, central engineering and production operations should populate the team in the first stage. The size and diversity of the team should grow from the identification step to the definition step as resources are allocated and plans developed. 

The project manager should assign either inspection staff for new facilities, the facility fire protection staff, or appropriate personnel at existing facilities the responsibility of monitoringthe activities of the contractor installingthe system. These duties should include ... 

The project manager should coordinate the acceptance test with installation contractors and appropriate facility personnel. The project manager should develop the testing protocol and the expected results. A review of the testing protocol and requirements should be shared with the groups involved in the testing. 

A contractor company represented in the DQO process by the project manager, the chemist, and the statistician will conduct project planning. The contractor company will provide the necessary resources and perform the work. The project budget and schedule are negotiable. A consulting company represented in the DQO process by the project manager and the chemist will perform the work the consultant will provide personnel for the operation of the treatment system. The project has a limited budget and will last for two years. 

Prior to the start of sampling we must make sure that the laboratory is prepared to meet the project-specific requirements contained in the SAP. We should always send the SAP to the Project Manager, who in turn will ensure that it is available to laboratory personnel. A meeting or a conference call with the Project Manager and other key laboratory staff prior to start of field work is always beneficial for establishing a common purpose and for building a relationship with the laboratory. 

The planning and preparation of either a new product or investigational product application requires a multidisciplinary approach. Most companies developing new products utilize formal project management systems to facilitate the collaboration between the technical disciplines, which may include personnel from research and development, manufacturing, formulation development, regulatory affairs, quality assurance, and other disciplines, as required. In addition to planning for the required elements, most FDA review divisions have specific preferences on how data should be analyzed and presented. When complex applications are planned, such as INDs, IDEs, PMAs, NDAs or BLAs it is critical for communications with the... 

The firm could have prevented this situation and citation by ensuring that the appropriate person was responsible for communicating with the FDA s PAI manager to effectively schedule the inspection. The appropriate person is someone who has adequate interface with and information from the various departments, units, and personnel that need to be inspection-ready. Ideally, one individual is selected to communicate with various units within the company as well as the FDA. This person could be the PAI project manager or someone in the QA area. It is essential that this individual be apprised of the status of critical inspection activities, such as equipment qualification, process validation, and overall inspection-readiness. 

This work was supported by EPRI through the Advanced Power Systems Division. Mr. Henry Schreiber was the Project Manager. Field sampling was conducted by Battelle Columbus personnel Paul Webb, Harry Leonard and William Baytos. Cooper Energy Services and Easton Utilities provided technical assistance and operated the fuel handling and engine systems during the tests. 

It may be beneficial where it is deemed cost effective and efficient for the completion of a project, for the project manager to distribute copies of the draft report to the appropriate project engineering and design personnel. This may allow these individuals to resolve recommendations as soon as possible and prior to the finalization of the report. This avoids costly changes in the design later in the process. 

---