PowerPoint Presentation: A PRESENTATION ON PROJECT PLANNING AND IMPLIMENTATION PROJECT MANAGEMENT NIMISHA FACULTY OF PHARMACY AMITY UNIVERSITY, LUCKNOW CAMPUS PROJECT: PROJECT A project is a temporary endeavor undertaken to create a unique product or service. Project management provides the processes, tools, techniques, skills and knowledge needed to manage a project . PowerPoint Presentation: Every project is different and that projects exist in an environment of change, uncertainty and inconsistency. “Project mgmt is a science” and that the processes of project mgmt are consistent across all industries and environments. Project mgmt is more, much more of an art than a science and application of project mgmt is not consistent across industries, environments and situations. For example, many of the elements of project management applied in the construction and telecom-munications do not work in pharmaceutical development. A PROJECT MANAGEMENT FRAMEWORK: A PROJECT MANAGEMENT FRAMEWORK A project management framework has six elements. like Project deﬁnition Project team and organization, Project planning, scheduling, and control Problem solving and decision making using proto-types Senior management review and control Proactive, real-time change management. PowerPoint Presentation: These are the key of successful mgmt of a new product development project. Project definition processes develop. The project scope and objectives The business case and the technologies utilized The project strategy or direction being pursued The sponsorship and championship for the new product Concept The ﬁnal product performance targets and deliverables. PROJECT DEFINITION-OBJECTIVE & SCOPE: PROJECT DEFINITION-OBJECTIVE & SCOPE Project objective and Scope- what is within and not within the project boundaries, The business case and market need, the technologies to be used to solve that business case, and the initiation, selling, and sponsoring of the project. The scope of the project includes deﬁnition of the ﬁnal product deliverable the level of work effort required to complete this project. Like a new pharmaceutical drug will be used to reduce long-term intractable pain, will be in an inject- able form, and will use existing packaging conﬁgura- tions in deﬁned concentrations and formulations. PowerPoint Presentation: The project scope , however, is much more time consuming and complex to develop and would include: The number, type, and cost of clinical studies or trials (including number of patients and sites) required in each phase of development to complete the project; The formulation, analytical chemistry, packaging and sterilization/microbiological work needed; and The manufacturing processes, equipment, and other resources required to produce the product PowerPoint Presentation: A project approval document or charter , includes the product scope, project objectives, business case, and ﬁnancial evaluation. Project objectives are also a key element of project deﬁnition and set the direction for a product develop- ment project . These objectives operate in an environment where trade-offs are necessary, and are often referred to as the triple constraint . Three constraints/Triple Constraints: Three constraints/Triple Constraints 1.Scope of work Requirements - Cost - Performance 2. Resources 3. Time-to-market PowerPoint Presentation: Due to the nature of new product development, uncertainty of the projects, high costs, limited resources concurrent process of project selling and support is required. Project Champions are individual within the organization who support the project and sell it to the management. Project Sponsors are the senior level executives whose support is needed to fund and provide resources for the project. Elements Of Successful Initial Project Deﬁnition:: Elements Of Successful Initial Project Deﬁnition: A proactive process of searching both externally and internally for new product concepts. Research for these new product concepts and funding for the same to assure that the concepts are developed to an appropriate level. A process to evaluate new product concepts PROJECT TEAM AND ORGANIZATION: PROJECT TEAM AND ORGANIZATION A team is a small number of people with complementary skills who are committed to a common purpose, performance goals, and approach for which they hold themselves mutually accountable. Team members must realize that they are part of a team. team to be most productive and effective, team members must collaborate with other team members, put aside their own personal or functional agenda, and use dialogue to develop a common understanding and create the best cross-functional approach for the project and the organization. PowerPoint Presentation: QUALITY OF TEAM MEMBERS : Committed, goal oriented, performance oriented, sacrifice habit, accountability ‘‘Core’’ or primary team and support teams -To keep the number of team members small. Core team members represent the different functions of an organization, have signiﬁcant authority and responsibility in the organization (especially for high priority projects), and have both specialist/technical and generalist/ business skills PowerPoint Presentation: . In the pain management example, the core team may include team members from: Program management Marketing management Clinical development Formulation development Analytical chemistry Process development Operations management Regulatory management. PowerPoint Presentation: Support teams would work on formulation development, clinical development, market introduction, and manufacturing process development. To be small and effective, a core team-12members. For major, high-priority projects each team member must have considerable authority and responsibility within their respective functional organization. PowerPoint Presentation: EACH TEAM MEMBER Ensures functional expertise on the project Represents functional perspective on the project Ensures functional deliverables are met Proactively raises functional issues that impact the team. ‘‘heavyweight’’- To designate team members with signiﬁcant authority and responsibility. Heavy weight team -where more decision making and problem solving authority and responsibility reside in the team rather than in the functions. PowerPoint Presentation: Heavy weight team Members Revise project tasks and content Establish project status reporting and other organizational responsibilities Participate in monitoring and improving team performance Share responsibility for ensuring effective team processes Examine issues from an executive point of view Understand, recognize, the boundaries of the project and team processes. PowerPoint Presentation: Depending on the needs of the project, either the functional or project perspective will be more important to its success. For example, a research project requires more of a technical specialization than a generalist perspective to be successful. ‘‘lightweight’’ team, one where the functional perspective is more important and decisions are made mainly within the functions 3.PROJECT PLANNING, SCHEDULING, AND CONTROL: 3.PROJECT PLANNING, SCHEDULING, AND CONTROL Development of the critical path method and the Project Evaluation and Review Technique (PERT) is considered to be the initiation of the modern practice of project management. The critical path method is a network analysis technique used to predict project duration by analyzing which sequence of activities or path most likely has the least amount of scheduling ﬂexibility or the least amount of ﬂoat. This critical path determines the earliest completion of the project. PowerPoint Presentation: The critical path method relies on one estimate for the duration of a task. PERT uses three estimates. most likely (i.e., the critical path method), worst case, and best case estimates. PowerPoint Presentation: A popular approach for team members to develop a project network diagram is a concept known as the ‘yellow sticky’’ method. The suggested steps of the ‘‘yellow sticky’’ method are as follows: 1. Identify the milestones that the project team will track with management along with target completion dates. 2. Identify the team member deliverables or responsibilities that need to be completed prior to the milestone dates. 3. Create the network diagram as follows: PowerPoint Presentation: Identify which tasks can be started today, based availability of information not upon availability of resources. Identify which tasks can be started after the initial tasks are completed, which tasks can be completed after that and so forth to the end of the project or the next major milestone. 4. Obtain team member commitments to deliverables—usually best accomplished after the ﬁrst planning meeting. 5. Negotiate between project milestone dates and team member deliverable dates. PowerPoint Presentation: Steps 1–3 of this planning method are best accomplished in a core team meeting, along with support team members. Steps 4 and 5 are best accomplished after the meeting when the team members have timeto evaluate their workload and commit to the deliverables. If there is a misalignment between management’s expectations for completion of major milestones, there are a number of options: Change the milestone date ‘‘Fast track’’ the project schedule, or ‘‘Crash’’ the project. PowerPoint Presentation: ‘‘Crashing’’ the project means to decrease the total project duration after analyzing a number of alternatives to determine how to get the maximum duration compression for the least cost. ‘‘Crashing’’ usually occurs by adding resources to reduce time. PowerPoint Presentation: INTEGRATED PROJECT PLAN The project scope and objectives The business case and ﬁnancial analysis and model of the project The project risks and issues with contingency plans, The project plan and schedule. The roles and responsibilities of the team members Functional and technical strategies (e.g., regulatory strategy, plans, and challenges) Performance measurements and incentives.