Computer Systems Validation (2005)

This conference will provide a forum for Validation and IT/IS Professionals to hear from other specialists about the technical implementation of legislation governing the validation of computer systems in the Pharmaceutical Industry and share their knowledge of controversial issues and real problems.

Hear from leading industry experts including:

• Dr Guy Wingate, Director, Global Computer Validation, GlaxoSmithKline, Global Manufacturing & Supply
• Pranay Butala, Head, Global Quality, AIS, Aventis
• Norbert Fritz, Head, Clinical Programming, F. Hoffman-La Roche
• Judi Boyle, Associate Director, R&D QA, External GMP & Part 11 Computer Validation Compliance, Boehringer-Ingelheim
• Karin Östergren, Associate Director, QA Computerised Systems, AstraZeneca
• Olaf Mölders, Global IT/IS Validation Manager, Bayer Healthcare
• Hani Kamel, Quality & Security Advisor, Novo Nordisk
• Richard Fazackerley, QA Validation Team Leader, Eli Lilly
• Susan Widlake, Computer Compliance Specialist, Amgen

The essential event on:

• VALIDATION & COMPLIANCE: Hear about business systems validation and FDA compliance for 21 CFR Part 11
• RISK BASED APPROACHES: Understand the current issues surrounding laboratory systems and information systems
• CLINICAL STUDY DATABASES: Gain an insight into how risk assessment can help to find the most suitable validation approach
• PLANNING & SCRIPT WRITING: Assess validation planning for success as well as risk and impact analysis
• NETWORK WITH KEY EXPERTS: Make valuable contacts with those at the forefront of development and implementation