IT Infrastructure and Network Qualification: Step-by-Step 2011

Key Topics

• FDA inspection/enforcement practices: examples for Warning Letters/483s
• Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
• The GAMP/ISPE Good Practices Guides
• The FDA Industry Guide: Cybersecurity for Networked Medical Devices
• Compliance concepts for infrastructure vs. networked systems
• Principles of network infrastructure qualification
• Qualification of PC clients, servers, data centers
• Configuration management and change control
• Maintenance of servers
• What and how much to test
• Documentation requirements
• How to ensure highest system uptime with on-line monitoring tools
• Going through a life FDA inspection

Who should Attend

• Everybody responsible for FDA compliance of computer systems
• IT managers and personnel
• All users of computer systems used in regulated environments
• Managers from purchasing, documentation and operations
• GLP/GMP/GCP auditors
• QA managers and personnel
• Teachers
• Consultants