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Computer+Systems+Validation+Masterclass.pdf
3-Day Masterclass
Join this interactive event with
Case Studies
8 Workshops
Discussion Sessions
Computer Systems
Validation Masterclass
14 - 16 May 2008, Prague, Czech Republic
SPEAKERS: PROGRAMME:
Kate Samways GAMP 5 Overview
KAS Associates Ltd, UK Roles, Responsibilities and
Governance
Dr Wolfgang Schumacher Writing Requirements Documents
F. Hoffmann-La Roche, Switzerland Advanced Risk Assessment - FMEA
Dr David Selby Design Specification, Design Review
and Risk Mitigation
Selby Hope International, UK
Risk Management applied to Elec-
tronic Record Controls
Code Review
Scaleability of Validation
Validating Spreadsheets
Change Control and Configuration
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