Auditing Systems for 21 CFR Part 11 Compliance 2012

Topics

• Regulatory Inspections of Computer Systems
• CFR Part 11 Requirements
• Training
• Required Policies and Procedures
• System Inventory Assessment - Preliminary Risk Assessment
• Performing a Comprehensive Inventory: Team Effort
• Remediation Plans and Schedules
• Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions
• Case Studies : Federal and State Regulatory Inspections
• Presenting to the Inspector

Who should Attend

• QA managers and personnel
• End-users responsible for applications and systems
• Senior Quality, Regulatory and Operations Management
• Information Technology managers and personnel
• Quality system auditors
• Regulatory Affairs staff