project management in pharmaceutical generic industry basics and standards
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Project Management
Jayesh Khatri
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How do we create, align, and arm our people and teams to complete projects faster?
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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.
Definition
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Three constraints
Scope
Cost Schedule
- Quality - Team
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Why do we need Project Management
Optimum utilization of ResourcesImprove the cost consumption
Reduce the time to Market
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US DoD Invented CPM & PERT
US DoD created Earned
Value and WBS
PMI proposed
triple constraint
s
PMI Published PMBOK
PMI Initiated
PP certificatio
n
Project Managers seeks best practices
The rise of Agile project management practices
1950s 1960s 1970s 1980s 1990s 2000s 2008~
History of Project Management
CPM - Critical Path ManagementPERT- Program Evaluation and Review technique
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Basics of Project Management
Initiation Planning Tracking, Monitoring & Controlling
Closure
WHY WHAT WHEN HOW WHO
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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 Charter
Project Planning:
- Micro schedule :Finalization of milestones timelines with key
stakeholders
- Highlight the Key milestones to focus on overall program
- Resource Mapping
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Project Monitoring & Tracking
- Execution
- Reviews
- Escalation
- Conflict Management
- Resource utilization
- Prioritization and de-prioritizationProject 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
Continued……
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Enterprise Project Mgmt
Enterprise deployment
Executive team
Power user
Developers
End user Manager
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New product development–Simple project plan (API)
Sr.No
Milestones Base Plan Current Plan Variance/Reason
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
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New product development–Simple project plan(Dosage)
Sr.No
Milestones Base Plan Current Plan Variance/Reason
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
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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
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Project
Project Mgmt
Project collaboration ……
Finance
SCM
RA
IP
ARD
R&D
MFG
QC/QA
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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, etc
* * ***
Matrix key: B = Brainstorming *** - main tool F = Fishbone/Ishikawa Diagrams ** - optional/secondary tool C = Critical Path Analysis Flow Diagrams * - sometimes useful G = Gantt Charts
project management toolsHere 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.
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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 ?
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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.
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Benefits centered Project Management
Project management beyond its role
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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.
What is Benefits Centered Project Management
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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)
Why Do We NeedBenefits Centered Project Management
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The changes inBenefits Centered Project Management
Revised contents of the Project Control Documents
Revised Project Management organization structure
New planning techniques
Revised Contents of the Project Control DocumentsThe use of a wider (benefits centered) definition of what the project is to deliver.• Re-structured User Requirements – lateral and vertical MOSCO.
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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 completed the Project
• Change Vision– The attitude and or culture changes needed
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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
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Key Elements of Project Work
People
Tools
Project
Processes
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New Terminologies
CCPM- Critical Chain Project Management
CPM – Critical path Management
PERT- Program Evaluation and Review technique
P2P- Project 2 Project
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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
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Companies win by getting the right things done faster than their
competition
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Thank You