Managing Project Closeout, Product Approval, Product Launch

Session 508
Project Management Track

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

Closing a project lifecycle includes the formal acceptance of the project and the ending thereof. Administrative activities include the archiving of the files and documenting lessons learned. This fifth and final stage will walk you through the process on managing the project closeout, product approval and product launch.

Session Description

The transition of personnel and project knowledge across the boundary between project closeout and product approval/launch are complex. This session will explore Project Management methodologies using Real World Case Studies and processes described in the Project Management Good Practice Guide and GAMP.

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

Understand the role of project management during project closeout
Complete and settle each contract applicable to the project
Finalize all activities of the process
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