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Speakers have shared very practical and real-life examples, excellent!

Global Network Services Qualification and Security Global Lead, Pfizer Inc.

This conference is very helpful for us. There are a lot of practical ideas that can be used to increase efficiency of our organization.

Senior Specialist Informatics Compliance, Hoffman La Roche

Featuring In-Depth Presentations, Case-Studies, Perspectives & Conversations on:

FDA Audits of Design Controls for Computerized Systems
Maintaining IT Compliance through Control Models and Standards [FDA, SOX, ISO, and Privacy, COBIT, ISSA, GAISP, CMM, UCP, ISO/ IEC 27001:2005]
Quality by Design (QbD): IT Infrastructure Requirement
GAMP5, ISO, ASTM, and Q8/9/10: How they fit in IT infrastructure and IT compliance?
Critical Thinking: TIR36 AAMI Approach to Software Validation
Network validation pros & cons
Archiving electronic records and documentation of the tests
Migration: from physical to virtual – design virtualization appropriately
Case study: Contract Negotiation – setting the right expectations with your clients
Backup, recovery, and archiving
Business continuity and disaster recovery

Why Are We Doing this Event?

Pharmaceutical companies are leveraging information technology (IT) to reduce the cost and time to discover, manufacture, and market their products. The industry faces significant pressures to bring low-cost, high-quality products and therapies to market despite rising development costs, including rising costs to comply with complex regulations. Remediation of IT systems as a result of nonconformance to quality and compliance requirements has significantly contributed to this cost escalation.
Ensuring information is both easily accessible and secure is critical. To be successful, pharmaceutical companies must ensure that the business and the supporting IT Infrastructure are in lock step with each other.

Who You Will Meet:

Leads, Directors, & Senior Managers of:

IT/ MIS
Informatics
Network and Data Center Operations
Software/ Application Development
Systems Analyst/ Integration
Computer/ Software Validation
Quality Assurance/ Quality Control
Quality Systems Engineering
Compliance/ Auditing

From the Following:

Pharmaceuticals
Biotech
Medical Device
Healthcare
Animal Health

In Collaboration with Advisory Board Members From:

Accenture
Bayer HealthCare
College of Computing and Digital Media, DePaul University
Premier Research Group
Covidien

If you are not yet ready to register, feel free to request a reminder nearer the time .

Conference Partners

Media Partners

[ Register Now] · [ Next: Main Conference Day 1: Tuesday, September 23, 2008 ]