Event:
Session:
WASHINGTON 2010 CONFERENCE
D01 GAMP Good Practice Guide: Manufacturing
Execution Systems - Guide Launch
Session Leader: Paul Irving, Greg Ruklic
Tuesday 8 June 2010
Dates:
Washington, DC
Location:
Tuesday, 8 June
Start
Time
7:30
9:00
9:30
End
Time
9:00
9:30
Presentation Title
Registration and Breakfast
Good Practice Guide Introduction and How to Save
Your Company Time and Money
A tour of the Good Practice Guide you will receive as an
attendee of this program and an introduction to the
Special Interest Group (SIG) that continues this work.
10:00 Strategic Management Approach
Embarking on a program to integrate the manufacturing
environment can be major effort for a company. This
presentation will discuss program organization and
business assessment methodology to define a roadmap
to the future state.
Speaker
Irving
Ruklic
Kanczewski
10:00
10:30
10:30 Networking Break
11:00 Models and Standards: Back to the Future
• How this guide builds upon and expands existing
standards (such as ISA 95 )
• Provides a foundation for understanding the
methodology presented in this guidance and what
accepted standards support application to industry
11:00
11:30 Manufacturing and Systems Domains: A Circle can
Ruklic
Define a Straighter Path
• A methodology to define the overall manufacturing
environment, and the included groups of related
functionality across systems.
• Technology-independent approach to specification and
verification
• Encourages a lean approach to defining overall
manufacturing environment and life cycle, not just
systems life cycles
11:30
12:00 Electronic Production Records (EPR) Methodology
• Common terminology and paper equivalents
• Recipe development, control and testing
• Compliance aspects
12:00
13:00 Lunch
Iovino
Lerner
13:00
13:30 Review by Exception
Irving
The history, justification and methodology (now in
GAMP®5) to reduce production record review time and
effort for disposition of intermediates/subassemblies and
products while maintaining a compliant approach
13:30
14:15 MES Good Practice Guide Regulatory Perspective
Wyn
14:15
15:00 MES Implementation Project
This case study will focus on key learning points related
to
• Complexity and organization
• Business process analysis
• Master data
• Systems interfaces
• Key people and key knowledge
• Governance issues
Brummerstedt
15:00
15:30
15:30 Networking Break
16:15 Real Example of the Guide Put Into Practice (Case
Elms
Rees
Study)
This case study will outline site implementation of MES
and will cover the pre-project site status, scope definition,
building of the project plan, and organization of the
project team. The validation and documentation approach
will be discussed, as well as the governance and
reporting strategy. As this is an on-going project, change
g
g
g from
management
and go-live
issues, such as moving
project design to operations and maintenance mode, will
be included.
16:15
16:45
16:45 Panel Q&A
17:00 Wrap up
17:00
Seminar Adjourns
**Please Note that Agendas are Subject to Change**
All Speakers
Irving
Ruklic