Department of Pharmacy, University of Malta in collaboration with CTP Tecnologie di
Processo, Italy
Supported by Malta Life Sciences Park
Course for Pharmaceutical Technology students and Stakeholders in the Pharmaceutical
Industry
Course Leader: Dr.ssa Anna Lidia Vignoli - IT Project Manager for CTP, Italy
Computer System Validation and Data Integrity in Pharmaceutical Processes
4th February 2016
Time
Items
Speaker
9:00 – 9:15 REGISTRATION
Introduction
Professor Lilian M. Azzopardi
Giulia Dini, CTP Tecnologie di Processo, Italy
Ing Joe Sammut, CEO Malta Life Sciences Park
Computer System Validation
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10:45 – 11:00
Short history
EU and US GMP rules
Electronic Record, Electronic Signature and Audit Trail
Good Automated Manufacturing Practice (GAMP)
Coffee Break
Validation Life Cycle
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11:00 – 13:00
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Concept Phase
Project Phase (Planning, Audit to suppliers, Different level of
specification, Configuration, Different level of verification,
Acceptance and Release in production and Risk Management)
Operation
Retirement
Considerations
13:00 – 13:15
QUESTIONS AND DISCUSSION
13:15 – 14:15
LUNCH
14:15 – 15:15
PLC (Programmable Logic Controller)
SCADA (Supervisory Control and Data Acquisition)
DCS (Distributed Control System)
15:15 – 15:30
Coffee Break
15:30 – 17:30
Data Integrity
 Human error
 Good Documentation Practice
 Data Integrity
 Data Handling
 Guidance for Industry, latest updating (MHRA and WHO)
Definitions
ALCOA
Data critically
17:30 – 17:45
QUESTIONS AND DISCUSSION