Common Sense Computer Validation for Regulated Systems

Venue: Dorint Hotel Don Giovanni Prague (CZ)

Location: Prague, Prague, Czech Republic

Event Date/Time: Jun 07, 2010 End Date/Time: Jun 08, 2010
Registration Date: Jun 07, 2010
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Course Abstract:
This course teaches a practical approach to computer validation based on requirements from around the world for companies subject to GMP, GLP, GCP, and 21 CFR Part 11 regulations. More than 20 years of validation experience is condensed in 2 days of interactive tutorials and case study exercises. Validation documents from real projects are used in group work activities to illustrate how to do validation, e.g., Validation Plan and report, Test Plan and report, test scripts, trace matrix, user requirements specification, etc. Strategies for Disaster Recovery and Business Continuity will be explored from their different views of emergency situations. Come prepared to participate in a highly interactive way and to network with others interested in the same subject.

Learning Objectives:

Participants will be able to –

Identify common themes for compliance of software and systems across all regulations
Describe the expected items in a set of industry standard validation documentation for Software Supplier Operational Qualification (OQ), Platform System Installation Qualification (IQ) and End User Performance Qualification (PQ)
Examine the expected items from a real system validation project
Apply Master Plan and Mini-Form practices to GMP/GLP/GCP systems
Differentiate between Business Continuity and Disaster Recovery Plans and Practices


Vinohradská 157-a 130 20 Prague
Czech Republic