Event:
Session:
WASHINGTON 2010 CONFERENCE
Session Leader:
Dates:
Location:
E07 - GAMP® Good Practice Guide: A Risk-based Approach to
Operation of GxP Computerized Systems
Winnie Cappucci, Kate Samways
Wednesday-Thursday 9-10 June 2010
Washington, D.C.
Wednesday, 9 June
Start
Time
7:30
9:00
9:15
End Time Presentation Title
9:00
9:15
10:00
Breakfast
Welcome and Introductions
Overview of GAMP® Good Practice Guide: A Risk-based Approach to
Operation of GxP Computerized Systems
• Why maintain control in operation
• Scope of the Guide
• The interactions between operational processes
10:00
10:30
11:15
10:30
11:15
12:00
Networking Break
System Handover: From Project to Operation
Support Services
• What services are required?
• Selecting the service provider
• Monitoring the service provider
• Exit strategies
12:00
13:00
13:00
13:45
Lunch
Change Management
• What is the scope of change management
(Planned, Unplanned, Repair, and Sys Admin)
• Why is it so difficult?
• Scaleability of the process (including system administration tasks)
• Role of the change management board
13:45
14:30
Incident Management Performance Monitoring, CAPA
• What is an incident?
• The relationship between the processes and process nesting
• What metrics make sense for which systems?
14:30
15:00
15:00
15:45
Networking Break
Data Migration and System Retirement
• Define Data Migration and the Data Migration Life Cycle
o Preproject
o Data Preparation and Mapping
o Translation and Verification
o Testing
o Final Planning and Migration
• Define System Retirement and Retirement Strategies
o Retirement
o Decommissioning
o Disposal
15:45
16:30
16:30
17:00
17:00
Business Continuity
• When is it required?
• What is the scope?
• How to prepare?
Q&A
Seminar Adjourns, Reception
Speaker
Samways
Samways
Perez
Reid
Stephenson
Wakeham
Cappucci
Samson
All Speakers
Thursday, 10 June
Start
Time
7:00
8:00
8:15
End Time Presentation Title
Speaker
8:00
8:15
8:45
Breakfast
Welcome to Day Two
How Good are Your Operational Processes? (benchmarking workshop)
• Review of each operational process with
delegates scoring themselves
• Results collated with feedback session later in the
day
8:45
10:00
FDA Part 11 Update and Q&A
10:00
10:30
10:30
11:15
Networking Break
Risk Ranking for Periodic Review Workshop
11:15
12:00
A Risk-Based Approach to Operational Control for Laboratory Informatics Rutherford
Systems
• Overview of operational controls
- Control Requirements
- Critical Support Processes
• Discussion and examples of some key operational controls
- Handover approaches
- Support services
- Incident management and CAPA
- Change and configuration management
- Periodic review
- Support processes
- Archiving and retrieval
12:00
13 00
13:00
13:00
13:30
13 30
Lunch
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Feedback
Benchmarking
• Review with delegates the results to show
strengths and weaknesses in operational controls
13:30
14:30
15:00
14:30
15:00
16:00
Inspection Trends in the EU and Internationally
Networking Break
Join the Interactive Q&A Session with D06
16:00
Seminar Adjourns
**Please Note that Agendas are Subject to Change**
Cappucci
Samways
Smith, FDA
Samways
Cappucci
Samways
S
Wyn
Tollefsen
Wyn