project planning and implementation

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PROJECT PLANNING The dictionary meaning of project is speculative imagination. It deals with the three dimension innovation vision risk. So it is a scheme of something to be done in a viable framework. According to encyclopedia of management – a project is an organized unit dedicated to the attainment of goal- the successful completion of a development project on time with in budget, in conformance with predetermined program specification .

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For example:-many of the elements of project management applied in the construction and telecommunication industries do not work in pharmaceutical development .

A project management framework:

A project management framework Six elements :- Project definition Project team and organization Project planning ,scheduling and control Problem solving and decision making using prototype Senior management review and control Proactive ,real time change management

Objectives of new product projects:

Objectives of new product projects resources Time-to-mark Scope of work requirement -cost -performance

New product “funnel”:

New product “funnel” New product launches Management reviews Contract Charter/integrated project plan Annual plan Cost reductions generics QEMs Co-development Internal research External research

Design of project team:

Design of project team Core team cross functional &small Formulation development team Manufacturing process development team Clinical development team Market introduction team

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Functional focus technical specialization Project focus & integration Project team member Project organization structures

PERT analysis:

PERT analysis P-project E-evaluation R-review and T-technique

Steps in the PERT Planning Process :

Steps in the PERT Planning Process PERT planning involves the following steps: Identify the specific activities and milestones. Determine the proper sequence of the activities. Construct a network diagram. Estimate the time required for each activity. Determine the critical path . Update the PERT chart as the project progresses.

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1.  Identify Activities and Milestones The activities are the tasks required to complete the project. The milestones are the events marking the beginning and end of one or more activities. It is helpful to list the tasks in a table that in later steps can be expanded to include information on sequence and duration.

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2.  Determine Activity Sequence This step may be combined with the activity identification step since the activity sequence is evident for some tasks. Other tasks may require more analysis to determine the exact order in which they must be performed.

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3.  Construct the Network Diagram Using the activity sequence information, a network diagram can be drawn showing the sequence of the serial and parallel activities. For the original activity-on-arc model, the activities are depicted by arrowed lines and milestones are depicted by circles or "bubbles". If done manually, several drafts may be required to correctly portray the relationships among activities. Software packages simplify this step by automatically converting tabular activity information into a network diagram.

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4.  Estimate Activity Times Weeks are a commonly used unit of time for activity completion, but any consistent unit of time can be used. A distinguishing feature of PERT is its ability to deal with uncertainty in activity completion times. For each activity, the model usually includes three time estimates: Optimistic time - generally the shortest time in which the activity can be completed. It is common practice to specify optimistic times to be three standard deviations from the mean so that there is approximately a 1% chance that the activity will be completed within the optimistic time. Most likely time - the completion time having the highest probability. Note that this time is different from the expected time . Pessimistic time - the longest time that an activity might require. Three standard deviations from the mean is commonly used for the pessimistic time. PERT assumes a beta probability distribution for the time estimates. For a beta distribution, the expected time for each activity can be approximated using the following weighted average: Expected time  =  ( Optimistic  +  4 x Most likely  +  Pessimistic ) / 6 This expected time may be displayed on the network diagram. To calculate the variance for each activity completion time, if three standard deviation times were selected for the optimistic and pessimistic times, then there are six standard deviations between them, so the variance is given by: [ ( Pessimistic  -  Optimistic ) / 6 ]2

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5.  Determine the Critical Path The critical path is determined by adding the times for the activities in each sequence and determining the longest path in the project. The critical path determines the total calendar time required for the project. If activities outside the critical path speed up or slow down (within limits), the total project time does not change. The amount of time that a non-critical path activity can be delayed without delaying the project is referred to as slack time . If the critical path is not immediately obvious, it may be helpful to determine the following four quantities for each activity: ES - Earliest Start time EF - Earliest Finish time LS - Latest Start time LF - Latest Finish time

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These times are calculated using the expected time for the relevant activities. The earliest start and finish times of each activity are determined by working forward through the network and determining the earliest time at which an activity can start and finish considering its predecessor activities. The latest start and finish times are the latest times that an activity can start and finish without delaying the project. LS and LF are found by working backward through the network. The difference in the latest and earliest finish of each activity is that activity's slack. The critical path then is the path through the network in which none of the activities have slack. The variance in the project completion time can be calculated by summing the variances in the completion times of the activities in the critical path. Given this variance, one can calculate the probability that the project will be completed by a certain date assuming a normal probability distribution for the critical path. The normal distribution assumption holds if the number of activities in the path is large enough for the central limit theorem to be applied. Since the critical path determines the completion date of the project, the project can be accelerated by adding the resources required to decrease the time for the activities in the critical path. Such a shortening of the project sometimes is referred to as project crashing .

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6.  Update as Project Progresses Make adjustments in the PERT chart as the project progresses. As the project unfolds, the estimated times can be replaced with actual times. In cases where there are delays, additional resources may be needed to stay on schedule and the PERT chart may be modified to reflect the new situation.

Benefits of PERT :

Benefits of PERT PERT is useful because it provides the following information: Expected project completion time. Probability of completion before a specified date. The critical path activities that directly impact the completion time. The activities that have slack time and that can lend resources to critical path activities. Activity start and end dates.

Limitations of PERT :

Limitations of PERT The following are some of PERT's weaknesses: The activity time estimates are somewhat subjective and depend on judgment. In cases where there is little experience in performing an activity, the numbers may be only a guess. In other cases, if the person or group performing the activity estimates the time there may be bias in the estimate. Even if the activity times are well-estimated, PERT assumes a beta distribution for these time estimates, but the actual distribution may be different. Even if the beta distribution assumption holds, PERT assumes that the probability distribution of the project completion time is the same as the that of the critical path. Because other paths can become the critical path if their associated activities are delayed, PERT consistently underestimates the expected project completion time. The underestimation of the project completion time due to alternate paths becoming critical is perhaps the most serious of these issues. To overcome this limitation, Monte Carlo simulations can be performed on the network to eliminate this optimistic bias in the expected project completion time.

Problem-Solving and Decision-Making Process :

Problem-Solving and Decision-Making Process Problem solving is a process in which we perceive and resolve a gap between a present situation and a desired goal, with the path to the goal blocked by known or unknown obstacles. In general, the situation is one not previously encountered, or where at least a specific solution from past experiences is not known. In contrast, decision making is a selection process where one of two or more possible solutions is chosen to reach a desired goal. The steps in both problem solving and decision making are quite similar. In fact, the terms are sometimes used interchangeably.

Drug development phases:

Drug development phases IND/CTX NDA/CPMP Adverse Rxn reporting Phase IV post mktg New indications inspection Phase I Phase II Phase III Long term Short time Formulation/ Chemistry Animal testing Initial synthesis Range 1-3yrs. Avg. 24 months Range 2-10yrs. Avg. 5-7yrs. Range 2months-7yrs Avg. 2yrs

Senior management and review and control:

Senior management and review and control Business issues and goals of the project Issues related to the consumer needs and the market place Resource management Corporate and business unit direction product line Sales and payback expectation Project schedule Timely introduction to market The availability and maturity of the technology to meet quality and cost targets

Proactive, real time change management :

Proactive, real time change management 1.State the real problem 2.Gather the relevant facts 3.Develop several alternative solution 4.Analyse and review impact of alternative 5.Adopt the best alternative 6.Tell everyone 7.Audit the outcome

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Financial evaluation for justification of a scope change Market introduction date Product unit cost Product performance Requirements Project development investment

Risk management plan :

Risk management plan High Low Probability occurrence Low High Financial impact Quadrant II Low probability High impact No contingency plan monitor Quadrant I Low probability Low impact No contingency plan Quadrant IV High probability High impact Develop contingency Plan Quadrant III High probability Low impact No contingency plan Monitor

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identification Key risk symptoms External sources Assumptions TCQ analysis Likelihood Opportunity and threats Effects Hide ability Corrective action Response control Contingency & Risk management scheme Project risk management quantification reserves

Forecasting :

Forecasting Sales and revenue forecasting Technology forecasting Other types of forecasting linear programming break even analyses simulations

Decision making tools:

Decision making tools Pay-off matrices Decision trees Other techniques

Strengths & weakness of planning tools:

Strengths & weakness of planning tools Weakness and problems Strengths and advantages


CHARACTERISTICS OF PROJECT 1. Investment phase 2. Expected return 3. Time limit 4. Location.

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1. Investment phase- project require finding support for its successful identification and execution. Project involves capital investment for the purpose of developing production or services facilities. 2. Expected return- capital investment is required in project but returns are expected only after the project completion. A person invest funds in project only when he for see a viable operation in future. It means that there must be a series of expected return in future. 3. Time limit- project requires a timely completion, so efforts are needed to realize the objective or completion of project with a framework of approved time and cost schedule. 4. Location- site selection is a tough decision and its require to evaluate the suitability of options. Availability of consumer market in that particular area or easy accessibility to labor laws. A raw material affects the decision of site selection.


PLANNING Planning is a written summery of what you hope to accomplish by being in work and how you intend to organize recourse to meet your goals


PLANNING- MAJOR BENEFITS 1. Helps in reducing an emotional bias. 2. Provides SWOT (strength, weakness, opportunities and threats) analysis. 3. Enable one to justify his/her plans &ideas. 4. Test the ideas on paper. 5. Helps one to develop a consistent strategy. 6. Helps in convincing other about the ideas.


PROJECT MANAGEMENT It is the process of planning and directing a project from its inception to its completion in a given time at a given cost of time at a given cost to generate a given result.



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1. INDENTATION- selection of a project after a careful scanning of the environment of investment opportunity & its likely return. 2. SELECTION- rational choice of a project in the light of objective & inherent constraints. 3. FORMULATION- translation of idea into a concrete project with scrutiny of its important preliminary aspects.

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4. APPRAISAL- searching scrutiny, analysis &evaluation of market, technical, financial, & economic variable. Assessing the profitability, return on investment& breakdown points. 5. IMPLEMENTATION- expeditious completion with in the allocated recourses. 6. REVIEW- judicious operation of a project with objective like, maximization of net present value maximization of return and increase in the rate of return at low risk.


PROJECT FORMULATION Project formulation is an important strategy of pre investment phase. It refers to a series of steps to be taken to convert an idea or aspiration into a feasible plan of action


STAGES OF PROJECT FORMULATION Process of project formulation involves following stages 1. Feasibility Analysis : This is very first stage in project formulation at this stage, the project ideas is examined from the point view to go in for a detailed investment proposal or not.

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2. Techno Economic analysis: In this step, Estimation of project demand, Potential and choice of optimal technology is made market analysis is also built in this step. 3. Project Design and Network Analysis: This important step defines individual activities which constitute, the project and their interrelationship with each other a detailed work m plan of the project is prepared with time allegation for each activity and presented in a network drawing 4. Input Analysis: The step asses the input requirement during the construction of the project and also during the operation the project

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5. Financial Analysis : this step mainly involves estimating the project cost , estimating its operating cost, and funds requirements. Financial analysis is also keeps in comparing various project proposal on a common Scale there by aiding the decision made 6. Cost Benefit Analysis : it is quantitative analysis. The overall value of a project is the main consideration here while the financial analysis justify a project from the profitability b point of view, Cost benefit analysis will consider the project from the overall viability point of view ( i.e. social, economical financial and ecological gain) 7. Pre Investment Phase: the project proposal a gets a formal and final shape at this stage, all the result obtained in the above steps are consolidated and various conclusion arrived at to a present a clear picture.


IMPLEMENTATION Implementation means to carry out ,to accomplish ,to fulfill, or to give practical effect & to ensure fluffiness by concrete measure Implementation – It involves the completion of numerous activities ( Project Component) by employing various resources – men , material , money and time so that project is translated into concrete reality

Project Implementation stages :

Project Implementation stages The purpose of any successful project implementation is to ensure that the project activities are completed within the scheduled & with in budget provision. 1. Initiation the project 2. Specifying and scheduling the work 3. Clarifying authority, responsibility and relationship 4. Obtaining resources 5. Establishing a control system 6. Directing and Controlling 7. terminating the project

1.Initiating the project :

1.Initiating the project Project initiation is the first step which is similar in many ways to he preparatory stages of project formulation. It involves obtaining approval of the proposed strategies, Project plan relevant budget and selection of project major and other major formulation.

2 .Specifying and scheduling the work :

2 .Specifying and scheduling the work After initiating the project , it becomes improvement to determine about the project plan by specifying the detail when , where and how the project activities would be done and whom would manage them in other words steps in the direction of defining the detail activity specification, Determining the inter relationship, specifying the manner of doing them, the person who are to mange them and likely duration by which the whole project is to be completed, have to be taken under the second stage.

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Following are some of the activities which are basically termed as important during course of project implementation • Finalization of technological parameter • Selection of equipment • Preparation of layout • Identification of infrastructure • Training of manpower

3.Clarifying authority, responsibility and relationship:

3.Clarifying authority, responsibility and relationship In the various member of this project team are made to aware of their relationship between authority and responsibility

Slide 48: 1. Sponsoring organization would be responsible for all the policy matters related to the project 2. Project manager has to see that project objectives are economically and efficiently accomplished. 3. Activity manager has to ensure that a group of activities assigned to him are completed with in time by consuming minimum resources

4.Obtaining resources :

4.Obtaining resources The discussion on resources would be taken up under the following three headings 1. Personnel 2. Finance 3. Material and equipment

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1.personnel The successful implementation of project depend on the efficiency and effectiveness with which personnel engaged at various levels undertake their task and achieve results In order to keep a track of the large variety of human resources required ILO has prescribed an international standard classification of occupations There must be availability of funds at the start and through out the schedule and phased life of a project . the flow of resources has to be planned that activities of the project do not slow down or suffer a set back 3.material equipment during the implementation stage for a project for its smooth progress required machinery , plant, equipment and other materials. It is possible to determine the exact requirement and time schedule of a particular activity from network chart & aggregator the resources requirement profit for the total project of the span

5.Establishing control system :

5.Establishing control system This stage Primary aim to designing and Establishing a Control System so that Management. At a different levels is not only able to direct and control the project from three parameters i.e. Time, Cost , And performance

6.Directing and controlling :

6.Directing and controlling Once the control system has been designed and established, now the management not only to motivate the staff for hard work but also to monitor and control the project functioning by taking immediate remedial measure based on an effective communication and decision making system

7.Terminating the project :

7.Terminating the project Literally termination means ending and in the context of project implementation, it spell out one of the four means:- • Normal Termination When the project is completed within stipulated resources and time • Non Termination : In this case the project become a normal functioning unit of the existing organization on its completion • Early Termination : In this case , there is a termination of project on account of no factors such as change in policy and program concerned availability of more prospective proposals. In other words these deals with the abandonment of the existing project. • Later Termination : It is generally the cost on account of time & cost over come.

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