Description
Auditing Systems for 21 CFR Part 11 Compliance 2011 is a webinar that covers topics such as: Regulatory Inspections of Computer Systems, 21CFR Part 11 Requirements, Training, Required Policies and Procedures, System Inventory Assessment - Preliminary Risk Assessment, Performing a Comprehensive Inventory, Remediation Plans and Schedules, Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions, Case Studies : Federal and State Regulatory Inspections and Presenting to the Inspector.
Auditing Systems for 21 CFR Part 11 Compliance 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 and Regulatory Affairs staff.