Project management in pharmaceutical generic industry basics and standards


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Project management in pharmaceutical generic industry basics and standards

  1. 1. ProjectManagement Jayesh Khatri 1
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  3. 3. Definition A project is a unique set of coordinated activities, with definite starting and finishing points, undertaken by an individual or team to meet specific objectives within defined time, cost and performance parameters as specified in the business case. Project Management is much more than the task carried out by a project manager. Project Management is combination of the Roles and Responsibilities of the individuals assigned to the project, the organisational structure that sets out clear reporting arrangements and the set of processes to deliver the required outcome. Project management ensures that everyone involved knows what is expected of them and helps to keep cost, time & risks under control. 3
  4. 4. Three constraints Scope - Quality - Team Cost Schedule 4
  5. 5. Why do we need Project Management Optimum utilization of Resources Improve the cost consumption Reduce the time to Market 5
  6. 6. History of Project Management1950s 1960s 1970s 1980s 1990s 2000s 2008~US DoD US DoD PMI Project The rise of created PMI PMIInvented Earned proposed Published Initiated PP Managers Agile project CPM & triple seeks best management Value and PMBOK certification PERT constraints practices practices WBS CPM - Critical Path Management PERT- Program Evaluation and Review technique 6
  7. 7. Basics of Project Management Planning Tracking, Monitoring Initiation Closure & Controlling WHY WHAT WHEN HOW WHO 7
  8. 8. StandardsProject Kick-off/Initiation- Project Initiation form- WBS- Identifying the team- Licensing activities- to be initiated- Finalization of Strategies- R&D, Sourcing, IP, Regulatory- Identification of Risks and mitigation plan- Macro schedule- Project CharterProject Planning:- Micro schedule :Finalization of milestones timelines with key stakeholders- Highlight the Key milestones to focus on overall program- Resource Mapping 8
  9. 9. Continued……Project Monitoring & Tracking- Execution- Reviews- Escalation- Conflict Management- Resource utilization- Prioritization and de-prioritizationProject Controlling:- Phase gate meetings- Budget controlProject Closure:- Variance- Base schedule Vs Actual timelines- Major Reasons for the delay- Base Cost Vs Actual Cost incurred (Project Margin difference)- Learning 9
  10. 10. Enterprise Project Mgmt Executive team End user Enterprise Power user Manager deployment Developers 10
  11. 11. Gantt Chart 11
  12. 12. New product development–Simple project plan (API)Sr. Milestones Base Plan Current Plan Variance/ReasonNo1 Project Kick-Off2 Availability of Test License3 RM Availability for Lab4 Lab Development Feasibility Analytical Method development Lab Optimization Lab Assurance batches Mfg License5 Tech Transfer6 RM procurement for Plant7 Trial batches8 Validation batches9 Stability data10 DMF filing 12
  13. 13. New product development–Simple project plan(Dosage)Sr. Milestones Base Plan Current Plan Variance/ReasonNo1 Project Kick-Off2 Availability of Test License3 Availability of Import License4 RM procurement for Lab6 Analytical Method development5 Lab Development/Mfg License application6 Pilot bio Initiation (BE NOC)7 Pilot bio completion8 RM procurement for Plant9 Exhibit batches10 Pivotal Study initiation11 Pivotal Study completion12 Stability data13 ANDA/EU Filing 13
  14. 14. Change Request formThe change request form is used to submit a request for change in aproject.This document can be used to avoid scope creep in a project. Scopecreep is adding work without corresponding updates to cost, scheduleand quality.Scope creep can render original project plans unachievable.The change request form summarizes the reasons and costsassociated with a particular change.Making any change request a formal part of the project managementprocess will allow for discussion of the change with all project teammembers and for everyone to be aware of any changes 14
  15. 15. Project collaboration …… Project Mgmt R&D SCM ARD Financ IP e QC/ RA QA MFG 15
  16. 16. project management toolsHere are examples and explanations of four commonly used tools in project planning andproject management, namely: Brainstorming, Fishbone Diagrams, Critical Path AnalysisFlow Diagrams, and Gantt Charts. Additionally and separately see business processmodelling and quality management, which contain related tools and methods aside fromthe main project management models shown below.The tools here each have their strengths and particular purposes, summarised as a basicguide in the matrix below. Matrix key: B = Brainstorming *** - main tool F = Fishbone/Ishikawa Diagrams ** - optional/secondary tool C = Critical Path Analysis Flow Diagrams * - sometimes useful G = Gantt Charts B F C G Project brainstorming and initial concepts, ideas, structures, aims, etc *** ** Gathering and identifying all elements, especially causal and hidden * *** ** factors Scheduling and timescales ** *** Identifying and sequencing parallel and interdependent activities and * *** * stages Financial - costings, budgets, revenues, profits, variances, etc * * ** *** Monitoring, forecasting, reporting * ** *** Troubleshooting, problem identification, diagnosis and solutions ** *** ** * Snapshot or map overview - non-sequential, non-scheduled ** *** Format for communications, presentations, updates, progress reports, 16 * * ***
  17. 17. The Plan-Driven “Manifesto”It is better to know than not- How much is this project going to cost ? How long will it take ? Who will need to be involved and when ? What can I expect and when can I expect it ? 17
  18. 18. Project prioritization and de-prioritizationMoSCoW is a prioritisation technique used in business analysis and Product development to reach acommon understanding with stakeholders on the importance they place on the delivery of eachrequirement - also known as MoSCoW prioritisation or MoSCoW analysis.According to A Guide to the Business Analysis Body of Knowledge, version 2.0[1], section, theMoSCoW categories are as follows:M - MUST: Describes a requirement that must be satisfied in the final solution for the solution to beconsidered a success.S - SHOULD: Represents a high-priority item that should be included in the solution if it is possible.This is often a critical requirement but one which can be satisfied in other ways if strictly necessary.C - COULD: Describes a requirement which is considered desirable but not necessary. This will beincluded if time and resources permit.W - WONT: Represents a requirement that stakeholders have agreed will not be implemented in agiven release, but may be considered for the future.The os in MoSCoW are added simply to make the word pronounceable, and are often left lowercase to indicate that they dont stand for anything. MOSCOW is an acceptable variant, with the osin upper case. 18
  19. 19. Benefits centered ProjectManagementProject management beyond its role 19
  20. 20. What is Benefits Centered Project ManagementThe efficient management of the execution of a projectwithin a controlled environment to:achieve the required benefits for the operation of the business.achieve a set of defined business outcomes.co-ordinate the planning, monitoring and control of the project withbenefit efficiency as the key. 20
  21. 21. Why Do We NeedBenefits Centered Project Management  The need for real success  Need to include the management of the benefits in the project A business benefit driven approach to delivering the project  The holistic approach  Effective/efficient use of scarce resources (M’s) 21
  22. 22. The changes inBenefits Centered Project ManagementRevised contents of the Project Control DocumentsRevised Project Management organization structureNew planning techniquesRevised Contents of the Project Control DocumentsThe use of a wider (benefits centered) definition of what the project is todeliver.• Re-structured User Requirements – lateral and vertical MOSCO. 22
  23. 23. Project Delivery Defined In• Business Vision– The business benefits or changes (Quantitative or Qualitative - to beobtained)• Operational Vision– What the organization or function will be like once we have completedthe Project• Change Vision– The attitude and or culture changes needed 23
  24. 24. Managing a Successful Project NeedsEmpowered decision makingLeadership at a senior levelActive management of the projectWell defined procedures for change control, conflict resolution, issue and riskmanagementOpen, flexible and well informed regimeFlexible and responsive top down decision makingCommon vocabulary and understood roles & responsibilitiesCollaboration and integrity amongst those involved in the ProjectEffective financial accountability 24
  25. 25. Key Elements of Project Work People Project Tools Processes 25
  26. 26. New TerminologiesCCPM- Critical Chain Project ManagementCPM – Critical path ManagementPERT- Program Evaluation and Review techniqueP2P- Project 2 Project 26
  27. 27. Key points- Internal strategies Timelines should be committed by respective Dept Head Special focus on key milestones dates Monthly planning sheet for key milestones Strong Internal Project Reviews – Fortnightly / Monthly (All dept head should beavailable) Internal meetings with R&D, PRC, Planning & Production team –Fortnightly(driven by Project Manager) Internal meetings with R&D/IPM/Sourcing team- Fortnightly/Monthly Active participation of all team members in Project kick-off meetings 27
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  29. 29. Thank You 29