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Project
Management


             Jayesh
             Khatri



                      1
2
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
Three constraints




               Scope




               - Quality
               - Team



        Cost               Schedule

                                      4
Why do we need Project Management


        Optimum utilization
        of Resources
        Improve the cost
        consumption
        Reduce the time to
        Market


                                    5
History of Project Management

1950s       1960s        1970s         1980s        1990s           2000s          2008~




US DoD        US DoD
                             PMI                                      Project     The rise of
              created                     PMI            PMI
Invented      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
Basics of Project Management




                   Planning   Tracking, Monitoring
     Initiation                                      Closure
                                 & Controlling




 WHY       WHAT   WHEN HOW    WHO

                                                               7
Standards
Project 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 Charter

Project Planning:
- Micro schedule :Finalization of milestones timelines with key
    stakeholders
- Highlight the Key milestones to focus on overall program
-    Resource Mapping

                                                                  8
Continued……
Project Monitoring & Tracking
- Execution
- Reviews
- Escalation
- Conflict Management
- Resource utilization
- Prioritization and de-prioritization
Project Controlling:
- Phase gate meetings
- Budget control
Project Closure:
- Variance- Base schedule Vs Actual timelines
- Major Reasons for the delay
- Base Cost Vs Actual Cost incurred (Project Margin difference)
- Learning
                                                                  9
Enterprise Project Mgmt

                            Executive
                              team




              End user    Enterprise    Power user
              Manager
                         deployment



                           Developers




                                                     10
Gantt Chart




              11
New product development–Simple project plan (API)

Sr.           Milestones             Base Plan   Current Plan   Variance/Reason
No
1          Project Kick-Off

2     Availability of Test License

3      RM Availability for Lab

4         Lab Development

              Feasibility

          Analytical Method
            development
           Lab Optimization

        Lab Assurance batches

             Mfg License

5           Tech Transfer

6     RM procurement for Plant

7            Trial batches

8         Validation batches

9           Stability data

10            DMF filing


                                                                                  12
New product development–Simple project plan(Dosage)

Sr.           Milestones              Base Plan   Current Plan   Variance/Reason
No
1           Project Kick-Off

2     Availability of Test License

3        Availability of Import
                License
4      RM procurement for Lab

6         Analytical Method
            development
5       Lab Development/Mfg
          License application
6     Pilot bio Initiation (BE NOC)

7        Pilot bio completion

8     RM procurement for Plant

9           Exhibit batches

10      Pivotal Study initiation

11     Pivotal Study completion

12           Stability data

13          ANDA/EU Filing
                                                                                   13
Change Request form

The change request form is used to submit a request for change in a
project.

This document can be used to avoid scope creep in a project. Scope
creep is adding work without corresponding updates to cost, schedule
and quality.

Scope creep can render original project plans unachievable.

The change request form summarizes the reasons and costs
associated with a particular change.

Making any change request a formal part of the project management
process will allow for discussion of the change with all project team
members and for everyone to be aware of any changes




                                                                        14
Project collaboration ……

                           Project
                           Mgmt




                            R&D

                                      SCM
                    ARD




                                             Financ
               IP                               e




                                       QC/
                      RA               QA

                                MFG

                                                      15
project management tools
Here are examples and explanations of four commonly used tools in project planning and
project management, namely: Brainstorming, Fishbone Diagrams, Critical Path Analysis
Flow Diagrams, and Gantt Charts. Additionally and separately see business process
modelling and quality management, which contain related tools and methods aside from
the main project management models shown below.
The tools here each have their strengths and particular purposes, summarised as a basic
guide 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
                                                                                              *     *    ***
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
Project prioritization and de-prioritization

MoSCoW is a prioritisation technique used in business analysis and Product development to reach a
common understanding with stakeholders on the importance they place on the delivery of each
requirement - also known as MoSCoW prioritisation or MoSCoW analysis.
According to A Guide to the Business Analysis Body of Knowledge, version 2.0[1], section 6.1.5.2, the
MoSCoW categories are as follows:

M - MUST: Describes a requirement that must be satisfied in the final solution for the solution to be
considered 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 be
included if time and resources permit.
W - WON'T: Represents a requirement that stakeholders have agreed will not be implemented in a
given release, but may be considered for the future.
The o's in MoSCoW are added simply to make the word pronounceable, and are often left lower
case to indicate that they don't stand for anything. MOSCOW is an acceptable variant, with the 'o's
in upper case.




                                                                                                           18
Benefits centered Project
Management
Project management beyond its role




                                     19
What is Benefits Centered Project Management


The efficient management of the execution of a project
within 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 with
benefit efficiency as the key.




                                                                        20
Why Do We Need
Benefits 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
The changes in
Benefits Centered Project Management


Revised contents of the Project Control Documents

Revised Project Management organization structure

New planning techniques



Revised Contents of the Project Control Documents

The use of a wider (benefits centered) definition of what the project is to
deliver.
• Re-structured User Requirements – lateral and vertical MOSCO.




                                                                              22
Project Delivery Defined In




• Business Vision
– The business benefits or changes (Quantitative or Qualitative - to be
obtained)

• Operational Vision
– What the organization or function will be like once we have completed
the Project

• Change Vision
– The attitude and or culture changes needed




                                                                          23
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 risk
management
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
Key Elements of Project Work




                      People




                      Project




              Tools             Processes




                                            25
New Terminologies

CCPM- Critical Chain Project Management

CPM – Critical path Management

PERT- Program Evaluation and Review technique

P2P- Project 2 Project




                                                26
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 be
available)
 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
28
Thank You


            29

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Project management in pharmaceutical generic industry basics and standards

  • 1. Project Management Jayesh Khatri 1
  • 2. 2
  • 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. Three constraints Scope - Quality - Team Cost Schedule 4
  • 5. Why do we need Project Management Optimum utilization of Resources Improve the cost consumption Reduce the time to Market 5
  • 6. History of Project Management 1950s 1960s 1970s 1980s 1990s 2000s 2008~ US DoD US DoD PMI Project The rise of created PMI PMI Invented 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. Basics of Project Management Planning Tracking, Monitoring Initiation Closure & Controlling WHY WHAT WHEN HOW WHO 7
  • 8. Standards Project 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 Charter Project Planning: - Micro schedule :Finalization of milestones timelines with key stakeholders - Highlight the Key milestones to focus on overall program - Resource Mapping 8
  • 9. Continued…… Project Monitoring & Tracking - Execution - Reviews - Escalation - Conflict Management - Resource utilization - Prioritization and de-prioritization Project Controlling: - Phase gate meetings - Budget control Project Closure: - Variance- Base schedule Vs Actual timelines - Major Reasons for the delay - Base Cost Vs Actual Cost incurred (Project Margin difference) - Learning 9
  • 10. Enterprise Project Mgmt Executive team End user Enterprise Power user Manager deployment Developers 10
  • 12. New product development–Simple project plan (API) Sr. Milestones Base Plan Current Plan Variance/Reason No 1 Project Kick-Off 2 Availability of Test License 3 RM Availability for Lab 4 Lab Development Feasibility Analytical Method development Lab Optimization Lab Assurance batches Mfg License 5 Tech Transfer 6 RM procurement for Plant 7 Trial batches 8 Validation batches 9 Stability data 10 DMF filing 12
  • 13. New product development–Simple project plan(Dosage) Sr. Milestones Base Plan Current Plan Variance/Reason No 1 Project Kick-Off 2 Availability of Test License 3 Availability of Import License 4 RM procurement for Lab 6 Analytical Method development 5 Lab Development/Mfg License application 6 Pilot bio Initiation (BE NOC) 7 Pilot bio completion 8 RM procurement for Plant 9 Exhibit batches 10 Pivotal Study initiation 11 Pivotal Study completion 12 Stability data 13 ANDA/EU Filing 13
  • 14. Change Request form The change request form is used to submit a request for change in a project. This document can be used to avoid scope creep in a project. Scope creep is adding work without corresponding updates to cost, schedule and quality. Scope creep can render original project plans unachievable. The change request form summarizes the reasons and costs associated with a particular change. Making any change request a formal part of the project management process will allow for discussion of the change with all project team members and for everyone to be aware of any changes 14
  • 15. Project collaboration …… Project Mgmt R&D SCM ARD Financ IP e QC/ RA QA MFG 15
  • 16. project management tools Here are examples and explanations of four commonly used tools in project planning and project management, namely: Brainstorming, Fishbone Diagrams, Critical Path Analysis Flow Diagrams, and Gantt Charts. Additionally and separately see business process modelling and quality management, which contain related tools and methods aside from the main project management models shown below. The tools here each have their strengths and particular purposes, summarised as a basic guide 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. 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. Project prioritization and de-prioritization MoSCoW is a prioritisation technique used in business analysis and Product development to reach a common understanding with stakeholders on the importance they place on the delivery of each requirement - also known as MoSCoW prioritisation or MoSCoW analysis. According to A Guide to the Business Analysis Body of Knowledge, version 2.0[1], section 6.1.5.2, the MoSCoW categories are as follows: M - MUST: Describes a requirement that must be satisfied in the final solution for the solution to be considered 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 be included if time and resources permit. W - WON'T: Represents a requirement that stakeholders have agreed will not be implemented in a given release, but may be considered for the future. The o's in MoSCoW are added simply to make the word pronounceable, and are often left lower case to indicate that they don't stand for anything. MOSCOW is an acceptable variant, with the 'o's in upper case. 18
  • 19. Benefits centered Project Management Project management beyond its role 19
  • 20. What is Benefits Centered Project Management The efficient management of the execution of a project within 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 with benefit efficiency as the key. 20
  • 21. Why Do We Need Benefits 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. The changes in Benefits Centered Project Management Revised contents of the Project Control Documents Revised Project Management organization structure New planning techniques Revised Contents of the Project Control Documents The use of a wider (benefits centered) definition of what the project is to deliver. • Re-structured User Requirements – lateral and vertical MOSCO. 22
  • 23. Project Delivery Defined In • Business Vision – The business benefits or changes (Quantitative or Qualitative - to be obtained) • Operational Vision – What the organization or function will be like once we have completed the Project • Change Vision – The attitude and or culture changes needed 23
  • 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 risk management 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. Key Elements of Project Work People Project Tools Processes 25
  • 26. New Terminologies CCPM- Critical Chain Project Management CPM – Critical path Management PERT- Program Evaluation and Review technique P2P- Project 2 Project 26
  • 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 be available)  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
  • 28. 28
  • 29. Thank You 29