Auditing Systems for 21 CFR Part 11 Compliance 2012 is a webinar that covers topics such as:
- 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
Auditing Systems for 21 CFR Part 11 Compliance 2012 brings together:
- 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