Good Practice Guide: Project Management for Pharmaceutical Industry
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Good Practice Guide: Project Management for Pharmaceutical Industry
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Author(s): Angelastro, Jamie; Barlow, David; Butler, Jeffrey H.; Davies, Nick C.; Errico, Stephen; Gibbs, Keith; Gunderlock, Rich; Honey, John; Hura, Leo; Iles-Smith, Peter; Kelly, Sean; Koncak, Dave; Lamson, Keith; Loxley, Paul; Lynam, Mick; McCann, Chris; McGlade, James W.; Melton, Trish, PhD; O'Donnell, Kevin; Odum, Jeffrey N., CPIP; Penfold, Alf; Phelan, Joe; Roberts, Andrew; Scherzer, Raymond H.; Shelden, Wade; Spanel, Greg; Stefanowicz, Matt; Theobald, Matthew; Thorne, Ian
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.
The Guide discusses: the tools and techniques supporting project delivery, the life cycle of a typical project in the pharmaceutical industry, and how compliance to pharmaceutical industry regulations is integrated with the project life cycle.
Table of Contents
Good Practice Guide: Project Management for Pharmaceutical Industry
Table of Contents pages: 1 2
- Preface 24
- Acknowledgements 35
- Table of Contents 57
- 1 Introduction 911
- 2 People Management 2325
- 2.1 Introduction 2325
- 2.2 Roles and Responsibilities: The Project Manager 2325
- 2.3 Roles and Responsibilities: Senior Stakeholders 2830
- 2.4 Roles and Responsibilities: The Project Team 3739
- 2.4.1 Critical Activity #1 – Structuring the Project Team’s Roles and Responsibilities to Ensure Delivery of the Project Scope 3840
- 2.4.2 Critical Activity #2 – Determining the Size and Type of Team Required to Meet the Project’s Objectives 3941
- 2.4.3 Critical Activity #3 – Determine Which Roles are Most Critical to Project Success and Determining How Best to Staff Those Roles 4446
- 2.4.4 Critical Activity #4 – Determining and Managing the Needs of the Team and Balancing Those Against Project Objectives 4446
- 2.4.5 Key Project Management Challenges 4749
- 2.5 Roles and Responsibilities: Consultants and Contractors 4749
- 2.6 Knowledge Management 5254
- 2.7 Language, Culture, and Communication 5557
- 3 Risk Management 6163
- 3.1 Introduction 6163
- 3.2 Pharmaceutical Risk Types 6567
- 3.3 Pharmaceutical Quality Risk Management 7173
- 3.4 Integrated Project Risk Management 7678
- 3.4.1 The Risk Management Life Cycle: Stage 1 and 2 – Project Initiation 7779
- 3.4.2 The Risk Management Life Cycle: Stage 3 – Project Delivery Planning 7880
- 3.4.3 The Risk Management Life Cycle: Stage 4 – Design 7981
- 3.4.4 The Risk Management Life Cycle: Stage 5 – Implementation 8284
- 3.4.5 The Risk Management Life Cycle: Stage 6 – Close-Out 8385
- 4 Project Initiation 8587
- 4.1 Introduction 8587
- 4.2 The Importance of Good Front End Definition 8587
- 4.3 Stage Gate Project Approval Process 8688
- 4.4 Stage 1 – Project Feasibility – Is this a Good Idea? 8991
- 4.5 Stage 2 – Project Conceptual Development – Identifying the Best Option 9597
- 4.5.1 Focus and Objectives 9597
- 4.5.2 Who Leads this Stage? 9597
- 4.5.3 Conceptual Development Stage Project Plan 9597
- 4.5.4 The Project Team Organization 9698
- 4.5.5 Conceptual Development Stage Kick Off – Statement of Requirements and URS 98100
- 4.5.6 Conceptual Development Stage Activities and Deliverables 100102
- 4.5.7 Value Management Reviews 102104
- 4.5.8 The Gatekeeping Decision at this Gate 104106
- 5 Project Delivery Planning 107109
- 5.1 Project Sponsor 107109
- 5.2 Project Scope 108110
- 5.3 Project Schedule 110112
- 5.4 Project Cost 113115
- 5.5 Project Controls 119121
- 5.6 Project Team 121123
- 5.7 Communication Plan 122124
- 5.8 Design Management Strategy 123125
- 5.9 Technology Strategy 125127
- 5.10 Procurement Plan 127129
- 5.11 Construction Plan 127129
- 5.12 Testing and Commissioning Strategy 128130
- 5.13 Project Start-Up Strategy 128130
- 5.14 Project Close-Out and Handover Strategy 130132
- 5.15 Completion of Project Delivery Planning 131133
- 6 Design Planning and Delivery 133135
- 6.1 Introduction 133135
- 6.2 Project Stage 1 Feasibility – Design Activities 134136
- 6.3 Project Stage 2 Conceptual Development – Design Activities 134136
- 6.4 Budget and Schedule Objectives 136138
- 6.5 Project Stage 3 Project Delivery Planning – Design Activities 138140
- 6.6 Project Stage 4 – Detailed Design Activities 140142
- 6.7 Completion of Design 148150
- 7 Implementation: Procurement 149151
- 8 Implementation: Construction 179181
Table of Contents pages: 1 2
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