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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Gantt Chart

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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