Education Sessions
Project Information Management (701)
| 26 October 13.00-17.00 | Track: Efficient and Effective Compliance |
ISPE CEUs: 0.4
(PDF Current as of 28 July 2008)
In the pharmaceutical industry, information about manufacturing asset design, fabrication, function and use is as important as the physical asset itself and in some cases, the absence of such information renders the asset unfit for use.
The Project Information Management (PIM) program supports information delivery and leverages trends such as increasing use of asset management technology tools, paperless asset delivery, and good engineering practice to provide a comprehensive program for asset information delivery and management.
The importance of assuring complete, accurate information for product, process, and equipment decisionmaking is a theme underscored throughout the ASTM E2500 standard and is fundamental to risk-based decision processes. The PIM program provides tools and processes to assure the timely delivery and ongoing management of accurate, complete asset information.
How You Will Benefit
At the end of this session, participants will be able to:
- Identify the fundamental components of a comprehensive project information management program
- Understand the importance of good engineering practices such as engineering change management and version control to maintaining information integrity
- Understand the benefits and challenges associated with asset information technology tools
- Examine their own project delivery programs and identify opportunities for improvement and for application of PIM principles and tools
- Understand the status of data and document standards development by ISPE C&Q COP Task Team
Technical Documents - www.ISPE.org/publications
Commissioning and Qualification Baseline® Guide
Who Should Attend
Professionals involved with capital project delivery including project management, Commissioning and Qualification, as well as validation, quality, maintenance, operations, IT, and process automation
ISPE Communities of Practice (COPs)
Commissioning and Qualification (C&Q), Project Management (PM), and Good Automated Manufacturing Practice (GAMP)
Session Leader
- Daniel Franklin, Regional Mgr, Compliance Svcs, IPS, USA
Session Speakers
- Allison Aschman, Managing Director, Singapore Office, Independent Project Analysis, Inc., Singapore
- David Kwilosz, Associate Consultant Engineer, Eli Lilly and Company, USA
- Dennis Naughton, Sr. Project Engineer, Eli Lilly and Company, USA