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47653845 Project Management

47653845 Project Management

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Published by vinniiee

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Published by: vinniiee on May 11, 2011
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Project Management - An OverviewProject management is a modern concept. Earlier (and even today) assignments inthe defence and construction industry used to be project based. Hence, project management assumed lot of significance for in those sectors. Today, its importance has become manifold and is being applied in such diverse industries and organisations as pharmaceuticals, chemicals, banking, hospitals, accounting, advertising, law, state and local governments and the United Nations Organisation.The concept of global village and the advent of globalisation of indigenous economies worldwide have made the business in all the sectors to become extremely competitive, more result oriented, structurally lean and technologically sophisticated. Cost reduction, process optimisation, capacity utilisation, reduction in the number of employees and such other strategies have become a common practice all over. However, the corporates are still not satisfied with the productivity of their organisations. It is here that project management comes into focus. Executives have finally realised that project management and productivity are related, both trying to make better utilisation of the existing resources.Project & Project ManagementBefore understanding project management, one must begin with definition of a project. A project can be considered to be any series of activities and tasks thathave a specific objective to be completed within certain specifications and in between defined start and end dates. A project will normally have funding limits.It consumes resources such as money, human resources and equipment.Project management may be defined as 'the planning, organising, directing and controlling of company resources for a relatively short term objective that has been established to complete specific goals and objectives.' The project management work will have identified people working for it. This may be called as projectteam. It will be lead by a project manager. Normally, the project management team members are drawn from different departments. They will be chosen by the topmanagement depending upon the objectives of the selected project.Broadly speaking, project management involves the following stages:1) Project planning2) Project monitoring, and3) ReportingThese three stages in turn include such items as:Project planning:- Stating the objectives of the project to be undertaken- Definition of work requirements- Definition of quantity of work- Definition of resources needed such as funds, materials, machines, new facilities and human resources, and- Determining time frame for the overall project and also scheduling its variousstagesProject monitoring:- Tracking progress- Comparing actual progress to the predicted or planned one- Analysing impact- Making adjustments (without compromising with the objectives of the project)- Keeping a check on budget utilisationReporting:The project manager has to make a comprehensive report at the end of the project
. The report has to be presented to the top management of the company or the plant. Normally, a project report will be a summary of all the activities taken bythe project management team to implement the planned project. It gives the necessary information and inputs to the top management for future decisions so as tomake better planning for the future projects and identify the areas of concern.Therefore, managing of a project can be considered as successful if the projectobjectives have been achieved:- Within the given time frame- Within the allotted budget- At the desired performance/technology level- While utilising the assigned resources in a better way (i.e., both effectivelyand efficiently)The project planning work is done by the project manager. However, the objectives part of the planning will be decided by the top management of the company or the plant depending upon the nature of the work.Potential benefitsThe potential benefits from project management are the following:- Identification of functional responsibilities- Avoidance of continuous reporting to and monitoring by the top management- Identification of time limits for scheduling of work- Measurement of accomplishment against plans- Early identification of potential problems- Improvement in budgeting of funds and allocation of resources for future planning- Knowing when the objectives can be met or even exceededObstaclesThe project management can become successful only by overcoming the following obstacles:- Complex nature of the project- Customer's special requirements i.e., other than the expected ones or the routinely asked ones- Changes in the organisational structure and the project management team- Project risks- Changes in technology- Changes in the desired outcome or specifications while working for a pre-determined project- Change in the priority status of the projectImportance of project management in pharmacyThe pharmaceutical industry is an extremely competitive sector. The very natureof drug development cycle or product development through its different stages and the competition amongst the pharmaceutical companies to ensure an early product launch to capture the market are just a few of the reasons to appreciate the growing importance of project management in the pharmaceutical industry. The concept of project management is beneficial in the following areas:- Clinical Research- Drug Development- Clinical Research Operations- Quality Assurance- Regulatory Affairs- Biostatistics- Pre-clinical Development
- Formulation Development- Technology Transfer- Process Improvement- Cost ReductionTo illustrate, technology transfer may be taken as an example. Technology transfer is a process of transferring technology of manufacturing a product from formulation development department (FD) to production department (PD). It is an inter-departmental exercise having great importance. A success in this activity willgive a large scale process of a new product for the company. (Note: Technology transfer can also take place between different organisations and from one plant of a company to another one.In this article, technology transfer from development departments like formulation development and analytical development to production and quality control hasbeen illustrated with the intention of explaining the benefits of project management as a practically useful tool to attain reach important goals).The senior most executive of the plant (such as vice president or general manager, GM of operations) forms a team consisting of the managers of the departmentsof formulation development (FD), analytical development (AD), quality assurance(QA), production (PD), quality control (QC), validation (VL), regulatory affairs(RA) and engineering (EN) for the purpose of technology transfer. The formulator and the analyst who developed the product and the analytical method respectively are also included in the team because, these two executives are responsible for technology transfer on the shop floor. The following are the objectives:1) To transfer the manufacturing technology of a product developed by FD to PD.2) To transfer the analytical method developed by AD to QC.3) To study the process parameters and feasibility of the same for a large scalebatch.4) To train the personnel of PD, QC and MT about the new product and its technical know-how required at their level for routine work.5) To decide on any modifications required in either manufacturing and/or analytical method.6) To recommend (on the basis of the outcome of technology transfer) any new facilities/machinery required to the top management.The team decides about the following plan of action for successful technology transfer:1) The formulator has to supervise the manufacturing process on the shop floor and educate the production personnel about the product developed and important aspects of the manufacturing process. He has to prepare the master production record (MPR) giving details of manufacturing method, specifications of raw materials, packaging materials, in-process controls and finished product. He will also prepare a stability study protocol to conduct stability studies, a critical requirement before commercialisation.2) The analyst shall supervise the analysis of all the inputs going into the product (including packaging materials - both primary and secondary), in-process samples' analysis and finished product's analysis. He has to educate the QC personnel in the process. He has to prepare a detailed procedure to perform the analytical method/s developed by him specifically for the product.3) QA has to ensure compliance of manufacturing process and analysis to the documents prepared by the formulator and the analyst. Any deviation will be noted byQA and suitable measures taken in consultation with concerned departments so that the same problems can be avoided during routine production campaign. They will ensure that the raw materials used in the technology transfer batch will compl

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