Early Phase Project Planning for Process/Product Development Projects

Session 208
Project Management Track

COP Sponsors: Project Management, Operations Management and the Japan Affiliate

As a Project Manager, it is our job to manage a project effectively to achieve success, and mitigate against project risk. To aid in that effort, the PM COP has developed a series of five distinct project case studies throughout the Conference. This session will be the second of five.

Session Description

The way a project is managed during the initial phase will determine the nature of that project’s success. If this stage is not performed well, it is unlikely that the project will be successful in meeting the business’ needs developed. The key project controls needed here are an understanding of the business environment and making sure that all necessary controls are incorporated into the project. Any deficiencies should be reported and a recommendation should be made to fix them.

The initiating stage should include a plan that encompasses the following areas:

Analyze the business needs and requirements in measurable goals
Reviewing of the current operations
Financial analysis of the costs and benefits including a budget
Stakeholder analysis, including users, and support personnel for the project
Project charter including costs, tasks, deliverables, and schedule

Applying the knowledge detailed in the ISPE Good Practice Guide: Project Management, delegates will explore the unique role a Project Manager plays in Process/Product Development.

At the conclusion of this session, participants will be able to:

Understand the role of project management during the project planning stage
Apply project management skills throughout the project
Describe the tasks required to manage a project throughout the lifecycle

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom