21 CFR Part 11 Compliance 2012 - Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

Why Should You Attend:

Can you show me how you manage your computer systems in compliance with 21CFR Part 11?

This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors.

Areas Covered in the seminar:
- 21CFR Part 11 Requirements.
- Regulatory Inspections of Computer Systems.
- Required Policies and Procedures.
- Training.
- Performing a Comprehensive Inventory: Team Effort.
- System Inventory Assessment - Preliminary Risk Assessment.
- Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions.
- Remediation Plans and Schedules.
- Presenting to the Inspector.
- Case Studies : Federal and State Regulatory Inspections.